MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 9MM THICKNESS SIZE G MEDIAL ARTICULAR SURFACE PROVISIONAL DO NOT IMPLANT; INSTRUMENT, KNEE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
Event or Problem Description
It was reported that trial was found cracked in the tray.There was no patient involvement.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.An investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
Event or Problem Description
No further event information available at the time of this report.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
Visual examination of the returned product identified signs of repeated use (nicked/gouged) and pieces fractured off outside of both holes.The device history record was reviewed and no discrepancies relevant to the reported event were found.The device has potential field age of over 5 years and exhibits signs of repeated use.The root cause of the reported event is attributed to wear and tear from repeated use over time.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: 9MM THICKNESS SIZE G MEDIAL ARTICULAR SURFACE PROVISIONAL DO NOT IMPLANT
• Common Device Name: INSTRUMENT, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17550754
• Report Number: 0001825034-2023-01917
• Device Sequence Number: 6694973
• Product Code: HSX
• UDI-Device Identifier: 00880304809970
• UDI-Public: (01)00880304809970(10)63799677
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K161592
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/27/2023

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: 42518100709
• Device Lot Number: 63799677
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2023
• Supplement Date Received by Manufacturer: 09/08/2023; 11/27/2023
• Initial Report FDA Received Date: 08/15/2023
• Supplement Report FDA Received Date: 09/25/2023; 11/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• 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
• Patient Sex: Unknown