MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TIBIAL ARTICULAR SURFACE PROVISIONAL SHIM SIZE CD 13 MM THICKNESS; INSTRUMENT

Model Number	N/A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the bearings were discovered missing from the tasp during the cleaning process.There was no patient involvement.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and corrected information.The complaint sample was evaluated and the reported event was confirmed through physical evaluation.The returned shim exhibited signs of repeated use (nicked/gouged) and both of each of the springs and ball bearings was disassembled and not returned for evaluation.The device history records were reviewed and no discrepancies were identified.A corrective and preventative action investigation into this issue was initiated to recommend against using ultrasonic cleaning as a sterilizing technique for these devices.The device was subsequently re-designed to account for this failure mode with a new locking mechanism.This device was manufactured prior to the design modification and therefore the root cause is the previously addressed design issue.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.

• Brand Name: TIBIAL ARTICULAR SURFACE PROVISIONAL SHIM SIZE CD 13 MM THICKNESS
• Common Device Name: INSTRUMENT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11614610
• Report Number: 0001822565-2021-00843
• Device Sequence Number: 3658631
• Product Code: JWH
• UDI-Device Identifier: 00889024245778
• UDI-Public: (01)00889024245778(10)62551087
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K113369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2021

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 Model Number: N/A
• Device Catalogue Number: 42527900303
• Device Lot Number: 62551087
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/22/2021
• Supplement Date Received by Manufacturer: 05/11/2021
• Initial Report FDA Received Date: 04/05/2021
• Supplement Report FDA Received Date: 05/11/2021
• 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: Z-1052-2015
• Patient Sequence Number: 1