MAUDE Adverse Event Report: Zimmer Biomet, Inc. FEMORAL AUGMENT SCREWDRIVER 3.5 MM HEX; Orthopedic manual surgical instrument, Screwdriver

Catalog Number	00598708900
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2026
Type of Reportable Event	Malfunction

• Brand Name: FEMORAL AUGMENT SCREWDRIVER 3.5 MM HEX
• Common Device Name: Orthopedic manual surgical instrument, Screwdriver
• Manufacturer (Section D): Zimmer Biomet, Inc.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): Zimmer Biomet, Inc.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; +1(574)526-0384
• MDR Report Key: 50551978
• Report Number: 0001822565-2026-03034
• Device Sequence Number: 13354466
• Product Code: HXX
• UDI-Device Identifier: 00889024219762
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/01/2026

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: 00598708900
• Device Lot Number: 63504718
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/18/2026
• 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: 08/11/2026
• Initial Report FDA Received Date: 09/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/28/2016
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown