MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FLEXIBLE SILICONE DRILL DRIVER; INSTRUMENT, HIP

Catalog Number	110010733
Medical Device Problem Codes	Fracture (1260); Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product was returned and evaluated.Visual examination of the returned product identified that the drill bit connection end of the flex driver had a retained fractured segment possibly from a drill bit within the internal locking portion.The fractured segment had a gouge from possible attempts to insert new drill bit.Scratches and dents are present on the drill bit connection end.Hudson connection end has scratches, dents, and gouges.No other damage noted.The retained fragment was not able to be removed during evaluation; therefore, functional test cannot be performed.Review of the device history record identified no deviations or anomalies during manufacturing.Insufficient information provided for the drill bit used.Unable to perform a compatibility check with the driver.Medical records were not provided.A definitive root cause cannot be determined.Based on the product review the complaint was confirmed.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.
Event or Problem Description
It was reported that the drill bit doesn¿t insert.The drill bit connection end of the flex driver was found to have a retained fractured segment during investigation.There was no reported patient involvement and no surgical delay.Attempts have been made, and no further information has been provided.

• Brand Name: FLEXIBLE SILICONE DRILL DRIVER
• Common Device Name: INSTRUMENT, HIP
• 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: 21971944
• Report Number: 0001825034-2025-01337
• Device Sequence Number: 8350956
• Product Code: HTW
• UDI-Device Identifier: 00887868466014
• UDI-Public: (01)00887868466014(11)230712(10)231215
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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
• Report Date (Section B): 05/06/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: 110010733
• Device Lot Number: 231215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2024
• 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: 05/06/2025
• Initial Report FDA Received Date: 05/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/12/2023
• 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