MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VNGD CRUCIATE PUNCH/TRIAL; IMPACTOR

Catalog Number	32-487276
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) d10: medical product: vngd cruciate punch/trial: catalog#32-487276, lot#z19h0983 g2: report source foreign: germany multiple mdr reports have been filed for this event.Please see associated report: 0001825034-2023-01932.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that during kit inspection, two trial instruments were found to be brittle which resulted in a fracture on the wing chisel.There was no patient involvement and no adverse events have been reported as a result of the malfunction.Due diligence is in progress for this event; to date no further information has been reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections have been updated: b4; b5; d9; h2; h3; h6; h10.Upon receipt of additional information, this device was determined to be not reportable.Visual examination of the returned product identified signs of wear and use however was not fractured.Wear of the reported device has not resulted in serious injury or harm to the patient for this event or any prior events with same or similar products.
Event or Problem Description
Upon receipt of additional information, this device was determined to be not reportable.Visual examination of the returned product identified signs of wear and use however was not fractured.Wear of the reported device has not resulted in serious injury or harm to the patient for this event or any prior events with same or similar products.

• Brand Name: VNGD CRUCIATE PUNCH/TRIAL
• Common Device Name: IMPACTOR
• 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: 17564332
• Report Number: 0001825034-2023-01933
• Device Sequence Number: 6967284
• Product Code: HWA
• UDI-Device Identifier: 00887868496448
• UDI-Public: (01)00887868496448(11)220726(10)ZB7273405
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2024

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: 32-487276
• Device Lot Number: ZB7273405
• 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: 07/28/2023
• Supplement Date Received by Manufacturer: 01/03/2024
• Initial Report FDA Received Date: 08/17/2023
• Supplement Report FDA Received Date: 01/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/26/2022
• 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: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Patient Sex: Unknown