Source: https://www.fda.gov/iceci/enforcementactions/warningletters/2016/ucm508895
Timestamp: 2019-02-22 18:20:09
Document Index: 361756467

Matched Legal Cases: ['§ 321', '§ 35', 'art 820', '§ 352', '§ 360', 'art 803', '§ 352', '§ 360', 'art 806', 'art 806', 'art 806', 'art 806', 'art 7']

Orthosoft, Inc. dba Zimmer CAS 5/27/16
Zimmer Biomet Holding, Inc.
Warsaw, TN 46580
During an inspection of your firm located at 75 Queen Street #3300, Montreal, Quebec, Canada, on January 25, 2016, through January 28, 2016, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the iAssist Knee System, Zimmer PSI Shoulder System, Zimmer PSI Knee System, and the Navitrack System. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321 (h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or function of the body.
This inspection revealed that these devices are adulterated within the meaning of section 501 (h) of the Act, 21 U.S.C. § 35 1(h), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. We received a response from Louis-Philippe Amiot, Vice President and General Manager, Zimmer CAS, dated February 19, 2016, concerning our investigator's observations noted on the Form FDA 483, List of Inspectional Observations, which was issued to your firm. Your firm's response dated March 31, 20 16, to the Form FDA 483 was not reviewed because it was not received within fifteen business days of issuance of the FDA 483. The response will be evaluated along with any other written material provided in response to the violations cited in this Warning Letter. These violations include, but are not limited to, the following:
1. Failure to establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR 820.1 OO(a). For example, the following deficiencies with your firm's Corrective and Preventive Action Procedure (b)(4), Rev 0, were noted:
a. The procedure does not describe how data will be analyzed to detect recurring quality problems; what sources of quality data are required for analysis, and does not require using appropriate statistical methodology where necessary to detect recurring quality problems.
b. The procedure does not include requirements to verify or validate the corrective and preventive action to ensure such action is effective and does not adversely affect the finished device where applicable.
c. The procedure does not ensure that the information related to quality problems and nonconforming product is disseminated to those directly responsible for assuring the quality of such product or the prevention of such problems.
d. The procedure does not include requirements to submit relevant information on identified quality problems as well as corrective and preventive actions for management review.
Your firm's response did not address this deficiency.
2. Failure to adequately establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a). For example, eight out of fourteen complaints reviewed by the investigator for FY15 did not include an MDR determination. Additionally, your firm's procedure does not include requirements to ensure complaints are evaluated in a timely manner to ensure that MDR reportability timeframes are met. For example:
a. Complaint #13902, dated 08/01/2015, describes the validation tool portion of the iASSIST Knee device breaking while the resident was impacting the tool onto the distal femur. An MDR determination was not conducted until 10/16/2015.
b. Complaint #13955, dated 09/10/2015, describes a pin of the validation tool portion of the iASSIST Knee device breaking while the surgeon was impacting the tool into the tibia. An MDR determination was not conducted until 10/14/2015.
c. Complaint #13966, dated 09/22/2015, describes a doctor facing an issue with femoral cut validation. An MDR determination was not conducted until 11/06/2015.
d. Complaint #13981, dated 10/14/2015, describes the validation tool portion of the iASSIST Knee device breaking during impaction by the surgeon. An MDR determination was not conducted until 11/28/2015.
The adequacy of your firm's response cannot be determined at this time. Your response indicated that your firm is in the process of implementing (b)(4) processes (b)(4), scheduled for implementation on May 31, 2016. Once implementation is complete, MDR reportability decisions will (b)(4). Your response also stated that these corporate processes include methods to ensure timely and uniform complaint processing and MDR assessments. However, your firm should complete its investigation and submit evidence of implementation of the corrective actions and effectiveness verification, as well as the results of a retrospective review of complaint files.
3. Failure to establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements, as required by 21 CFR 820.50. For example, your firm's procedure, (b)(4), "Purchasing," requires (b)(4).
However, your firm indicated that your purchasing control procedure does not list audit criteria. Your firm has not established how supplier audits will ensure that the firm has evaluated potential suppliers, contractors, consultants on the basis of their ability to meet specified requirements, including quality requirements.
The adequacy of your firm's response cannot be determined at this time. Your firm should complete its investigation and submitted evidence of implementation of the corrective actions and effectiveness verification as well as the results of its retrospective review of supplier audit documentation.
4. Failure to maintain device master records (DMR's), as required by 21 CFR 820.181. For example, your firm has not established a DMR for the iASSIST Knee device to include or refer to the location of: device specifications; production process specifications; quality assurance procedures and specifications; packaging and labeling specifications; and installation, maintenance, and servicing procedures and methods for the iASSIST Knee device.
The adequacy of your firm's response cannot be determined at this time. Your firm should complete its investigation and submitted evidence of implementation of a corrective actions and effectiveness verification.
5. Failure to establish and maintain adequate procedures to ensure that equipment is routinely calibrated, inspected, checked, and maintained, that includes provisions for handling, preservation, and storage of equipment, so that its accuracy and fitness for use are maintained, as required by 21 CFR 820.72(a). For example, your firm's calibration procedure, (b)(4), Calibration, Rev. 14, does not include provisions for handling, preservation, and storage of equipment, so that its accuracy and fitness for use are maintained.
6. Failure to establish and maintain procedures for quality audits and conduct such audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system, as required by 21 CFR 820.22. Specifically, your firm's procedure, (b)(4), Internal Audits, Rev. 12, does not include requirements tore-audit areas that have been found to be deficient, as necessary.
The adequacy of your firm's response cannot be determined at this time. Your firm should complete its investigation and submitted evidence of implementation of the corrective actions and effectiveness verification, as well as the results of its retrospective review of previous internal audits documentation.
Our inspection also revealed that your firm's iASSIST Knee System is misbranded under Section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that your firm failed or refused to furnish material or information regarding the devices that is required by or under Section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 803- Medical Device Reporting. Significant deviations include, but are not limited to:
7. Failure to adequately develop, maintain and implement written MDR procedures, as required by 21 CFR 803.17. For example: After reviewing your firm's MDR procedures titled "Complaint Management" (b)(4), Rev. 21, dated January 22, 2016 (Exhibit 10); and, "Device Vigilance- USA Declaration of Reportable Event to FDA" (b)(4), Rev. 3, dated November 27, 2014, the following issues were noted:
a. Your firm's MDR procedure does riot establish internal systems that provide for timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements. For example, the procedure omits definitions of the terms "become aware," "caused or contributed," from 21 CFR 803.3, and the definition for the term "reasonably suggests," found in 803.20(c)(1). The exclusion of the definitions for these terms from the procedure may lead your firm to make an incorrect reportability decision when evaluating a complaint that may meet the criteria for reporting under 21 CFR 803.50(a).
b. Your firm's MDR procedure does not establish internal systems that provide for timely transmission of complete medical device reports. Specifically, the following are not addressed:
i. The circumstances under which your firm must submit initial 30 days, as supplemental or follow-up, 5 day reports and the requirements for such reports.
ii. The procedure does not include a reference for the submission of MDR re reportable events using the mandatory 3500A or electronic equivalent.
iii. How your firm will submit all information reasonably known to it for each event. Specifically, which sections of the 3500A will need to be completed to include all information found in the firm's possession and any information that becomes available as a result of a reasonable follow up within its firm.
c. Your firm's MDR procedure does not describe how it will address documentation and record-keeping requirements, including systems that ensure access to information that facilitates timely follow-up and inspection by FDA.
Your firm should adjust its MDR procedure accordingly to include a process for submitting MDRs electronically in accordance with the Final Rule for electronic Medical Device Reporting (eMDR) published in the Federal Register on February 14, 2014. In addition, your firm will need to establish an eMDR account in order to submit MDRs electronically.
We reviewed your firm's response dated February 19, 2016, and conclude that it is not adequate. Your firm did not include a revised MDR procedure in its response.
Our inspection also revealed that your devices are misbranded under section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that your firm failed or refused to furnish material or information respecting the device that is required by or under section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 806 - Medical Device; Reports of Corrections and Removals. Significant violations include, but are not limited to, the following:
8. Failure to submit a Report of Correction or Removal for a medical device correction or removal initiated to reduce a risk to health or to remedy a violation of the Act caused by the device, which may present a risk to health, as required by 21 CFR 806.10. For example:
a. Your firm initiated a correction in November 2007 and May 26, 2008, for the Orthosoft Knee Universal CAS Software 2.3.2, due to a complaint relating to Right/Left knee Selection issues, Extension/Flexion Gap Assessment issues, and the SKS incorrect offset parameter value. Your firm conducted a correction or removal of these devices; however, no report was filed to FDA within 10 working days of initiating this correction.
b. Your firm initiated a removal in June 2008, of Sesamoid Plasty CAS workstation/base and column assemblies 52 1.025 in the field, because the workstation could potentially collapse and fall on a user if an attempt was made to fold the workstation without first removing the camera and arm. Your firm conducted a removal of these devices; however, no report was filed to FDA within 10 working days of initiating this removal.
c. Your firm initiated a removal in 2008, of Unicondylar Digitizer 108.098 instruments from the field, due to feedback received from surgeon that the newly modified software application was incompatible with the Unicondylar Digitizer instrument, causing large off-scale errors. Your firm conducted a removal of these devices; however, no report was filed to FDA within 10 working days of initiating this removal.
d. Your firm initiated a correction in July and August 2008, for the Magnetic Offset Paddle 108.117, due to a complaint relating to Anterior Cortex Digitization, Implant Tolerance Interpretation Issues, and Software Issues. Your firm conducted a correction of these devices; however, no report was filed to FDA within 10 working days of initiating this correction.
e. Your firm initiated a removal in October 2010, of NDI P7 Position Sensors, because the camera components of the sensor could potentially malfunction, resulting in an interruption of the CAS system, and causing the display of positional data to stop during surgery. Your firm conducted a removal of these devices; however, no report was filed to FDA within 10 working days of initiating this removal.
f. Your firm initiated a correction in December 2011 for the Orthosoft Knee Universal CAS Software 2.3.2, due to a complaint that the software can malfunction, resulting in stalling during the preoperative calibration of the Universal Holding Platform, which in tum causes a delay in surgery or the need to complete the surgery using a conventional surgical technique. Your firm conducted a correction of these devices; however, no report was filed to FDA within 10 working days of initiating this correction.
9. Failure to keep a record that contains a justification for not reporting the correction or removal action to FDA which shall contain conclusions and any follow-ups, and be reviewed and evaluated by a designated person, as required by 21 CFR Part 806.20. For example: Your firm initiated a recall in June 2008, due to a complaint that the male bracket -female bracket assembles 521.158 and 521.159, used for holding the tracking camera to the workstation had "notable" freeplay which made the camera difficult to use. However, the records provided do not contain a justification for not reporting, nor a signature as evidence that the record was reviewed and evaluated by a designated person. Your firm did not keep a record that contains a justification for not reporting the correction or removal action to FDA which contains conclusions and any follow-ups, that was reviewed and evaluated by a designated person, as required by 21 CFR Part 806.20.
Your firm should update its procedures to follow the requirements under 21 CFR Part 806 Medical Devices; Reports of Corrections and Removals, and the guidance provided by the 21 CFR Part 7 Recall Policy, to ensure that all required information is provided or documented. In addition, your firm should refer to CDRH recall classifications to evaluate future corrections and removals, thereby maintaining consistency in their Health Hazard Evaluations and compliance with reporting requirements. Further, your firm should conduct health risk assessments following the definition of risk to health in 21 CFR 806.2(j), to support the reporting decisions for future medical device corrections or removals.
Your firm's response should be sent to: Food and Drug Administration, Center for Devices and Radiological Health, Office of Compliance, Field Inspections Support Branch, White Oak Building 66, Rm 2622, 10903 New Hampshire Ave., Silver Spring, MD 20993. Refer to CMS case# 496307 when replying. If you have any questions about the contents of this letter, please contact: Daniel Walter, Chief, Foreign Enforcement Branch, at feb@fda.hhs.gov (email) or + 1(240)402-4020 (telephone), or + 1(301)847-8138 (fax).
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm's facility. It is your firm's responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm's manufacturing and quality management systems. Your firm should investigate and determine the causes of the violations, and take prompt actions to correct the violations and bring the products into compliance.
S. Dale Miller
Phone: 5742676131 ext 4962
Email: dale.miller@zimmerbiomet.com