MAUDE Adverse Event Report: BIOMET MICROFIXATION T15 HEXALOBE DRIVE SILVER; DRIVER, PROSTHESIS

Catalog Number	201.047.15
Medical Device Problem Codes	Material Twisted/Bent (2981); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device had an unknown malfunction.However, once product was returned it was noted that the tip was twisted and cracked.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).The device was returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information and/or corrected information.Updated: b3, b5, g3, h1, h2, h3, h6 and h11.Complaint sample was evaluated, and the reported event was confirmed.An investigation was conducted on the returned driver.The driver shows signs of multiple uses including heavy marking and scratching on the driver surface.Further inspection of the product tip shows that the tip has twisted and has also chipped in several locations on the gripping.A dimensional analysis is unable to be completed due to damage to the product tip.Dhr was reviewed and no discrepancies related to the reported event were found.Root cause was unable to be determined.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
It was reported that during restock within the sterilization department at the hospital, the device looked malfunctioned and possibly warped.There was no patient involvement.However, once product was returned it was noted that the tip was twisted and cracked.Attempts have been made and no further information has been provided.

• Brand Name: T15 HEXALOBE DRIVE SILVER
• Common Device Name: DRIVER, PROSTHESIS
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 23923431
• Report Number: 0001032347-2025-00486
• Device Sequence Number: 9013265
• Product Code: HWR
• UDI-Device Identifier: 00851599007655
• UDI-Public: (01)00851599007655(10)1118103
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2026

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: 201.047.15
• Device Lot Number: 1118103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2025
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2025
• Supplement Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 12/30/2025
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2018
• 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: Unknown