MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE REGULAR CONSTRAINT YELLOW/C-H 17 MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-04144.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that during an initial total knee arthroplasty, a scrub tech accidentally threw out the locking screw for a tibial insert.A screw was retrieved from a thinner tibial insert and was attempted to be used, but it would not lock the tibial insert into the tibial tray.The procedure was completed with a screw from another tibial insert of the same size.Attempts to obtain additional information have been made; however, no more is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Evaluation of the returned screw (item #(b)(4)), which was packaged with the articular surface item #(b)(4), lot #63880005 identified no visible damage to the threads.The screw passed the dimensional analysis and was conforming to print specifications.Medical records were not provided.However, the information provided indicates that the decision to use the screw from a non-compatible product was an error, before a screw of the correct size was finally used.Review of the device history record(s) for item #90597003017, lot #63880005 and the associated screw #00596019002, lot #63886023 identified no deviations or anomalies related to the reported issue during manufacturing.Review of the products determined that no failure was found as the products are within specification(s).No further investigation or action is required after review.The wrong screw (too short) was selected to assemble the articular surface to the tibial implant.The root cause of the reported issue is attributed to a user error.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: ARTICULAR SURFACE REGULAR CONSTRAINT YELLOW/C-H 17 MM
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11029311
• Report Number: 0001822565-2020-04143
• Device Sequence Number: 3487415
• Product Code: JWH
• UDI-Device Identifier: 00889024263598
• UDI-Public: (01)00889024263598(17)251231(10)63880005
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2025
• Device Model Number: N/A
• Device Catalogue Number: 90597003017
• Device Lot Number: 63880005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/24/2020
• Supplement Date Received by Manufacturer: 02/24/2021
• Initial Report FDA Received Date: 12/17/2020
• Supplement Report FDA Received Date: 02/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1