MAUDE Adverse Event Report: ZIMMER BIOMET, INC. LOCKING FEMORAL IMPACTOR PAD DO NOT IMPLANT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	42509909000
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an initial knee procedure, the impactor pad fractured during impaction of the femoral component.There was no patient impact and no adverse events have been reported as a result of the malfunction.
Additional Manufacturer Narrative
(b)(4).The product has been received by zimmer biomet and the investigation is in process.Upon completion of the investigation, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Visual evaluation of the returned product confirmed that the device is fractured.Device history record was reviewed and no discrepancies related to the reported event were found.Investigation results concluded that the reported event is attributed to wear and tear from the six plus (6+) years of use in the field.Complaint sample was evaluated and the reported event was confirmed.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.
Event or Problem Description
No further event information at time of this report.

• Brand Name: LOCKING FEMORAL IMPACTOR PAD DO NOT IMPLANT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 18184018
• Report Number: 0001825034-2023-02724
• Device Sequence Number: 7625633
• Product Code: HWA
• UDI-Device Identifier: 00880304809352
• UDI-Public: (01)00880304809352(10)63713419
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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
• Report Date (Section B): 02/12/2024

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 Catalogue Number: 42509909000
• Device Lot Number: 63713419
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2023
• 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: 10/31/2023
• Supplement Date Received by Manufacturer: 02/09/2024
• Initial Report FDA Received Date: 11/21/2023
• Supplement Report FDA Received Date: 02/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/14/2017
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose