MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL AUGMENT SCREWDRIVER 3.5 MM HEX; INSTRUMENT, KNEE

Catalog Number	00598708900
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).D10: unknown, tibial plate, unknown lot.G2: foreign: south africa.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 3.5mm hex driver tip broke during removal of a screw, this occurred during the procedure, but the patient was not negatively impacted at all as tip got stuck in screw on tibial plate.Surgical technique was utilized.There was no surgical delay.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; d2; g1; g3; g6; h1; h2.
Event or Problem Description
It was further reported the device fractured at the yield point.The surgeon noted the screwdriver tip seemed stripped and not in hex shape.The fractured tip was removed along with the screw using a screw set from the hospital.
Event or Problem Description
There is no update to the prior event description provided.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: b4, b5, g3, g6, h2, h3, h6, h11.Corrected data: h6 component codes.A visual inspection of the provided photographs identified a screwdriver with a fractured tip.Due to the limitations of the images, it could not be determined whether the device was stripped.As no product was returned, no further evaluation can be conducted.A review of the device history record identified no deviations or anomalies during manufacturing.The reported event is not related to a combination of products; therefore, a compatibility review is not applicable.A review of complaint history identified additional similar complaints for the reported item and part and lot combination.Complaints are monitored through monthly complaint review in order to identify potential adverse trends.A definitive root cause cannot be determined.If any further information is found that would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: FEMORAL AUGMENT SCREWDRIVER 3.5 MM HEX
• Common Device Name: INSTRUMENT, KNEE
• 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 ; 5745260384
• MDR Report Key: 22420160
• Report Number: 0001822565-2025-02394
• Device Sequence Number: 21037187
• Product Code: HXX
• UDI-Device Identifier: 00889024219762
• UDI-Public: (01)00889024219762(10)64337804
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: NI
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/03/2025

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: 00598708900
• Device Lot Number: 64337804
• Was Device Available for Evaluation?: No
• 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: 06/10/2025
• Supplement Date Received by Manufacturer: 07/08/2025; 09/08/2025
• Initial Report FDA Received Date: 07/07/2025
• Supplement Report FDA Received Date: 08/07/2025; 10/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2019
• 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 H11.
• Patient Sex: Unknown