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

Catalog Number	201.047.15
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint (b)(4).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 the blade fractured with the tip being fractured off.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d4, d9, g3, g6, h2, h3, h4, h6, h11.A visual inspection was conducted on the qty one 201.047.15 blade lot number 1123101 and qty one 201.047.15 lot number 1122416.Both blades show signs of multiple uses including heavy marking and scratching on the blade surfaces.Further inspection shows that both blades have twisted/ bent.The complaint for both blades is confirmed.A determination cannot be made as to what caused the blades to twist/ bend.Review of the dhr's identified no deviations or anomalies.Supplier dhr reviews were not performed as products have approximate field ages of 1 and 2 years, with an unknown number of uses.Visual inspection shows signs of multiple uses included marking/ scratching on the product surface and there is no indication that a manufacturing deficiency occurred.Harm severity 1/2 non-reportable.A definitive root cause cannot be determined.The reported event is confirmed, based on product return.The device evaluation found that the device was not fractured, but rather bent/twisted.This is not a reportable malfunction and based on available information, the event did not contribute to patient injury.Therefore, this would not be considered a reportable event.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: 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: 21633028
• Report Number: 0001032347-2025-00134
• Device Sequence Number: 9235480
• Product Code: HWR
• UDI-Device Identifier: 00851599007655
• UDI-Public: (01)00851599007655(10)1122416
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2025

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
• Device Catalogue Number: 201.047.15
• Device Lot Number: 1122416
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2025
• Supplement Date Received by Manufacturer: 07/01/2025
• Initial Report FDA Received Date: 03/18/2025
• Supplement Report FDA Received Date: 07/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/05/2023
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown