MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 1.3 MM SQUARE SCREWDRIVER

Catalog Number	231218012
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2: foreign- canada.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.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 tip of the screwdriver was broken and did not capture the screws properly.No adverse event has been reported as a result of the malfunction.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4, b5, d9, g3, g6, h2, h3, h6, h11 visual examination of the returned product/provided pictures identified the tip of the driver bit is broken.The print has a chamfer call out on it and there is no chamfer at the tip of the returned driver bit.Item and lot numbers are confirmed to match the complaint.There is some damage on the edges of the bit just above the fractured tip.Review of the device history record(s) identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.The reported event is confirmed by returned device.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
No further event information is available at the time of this report.

• Brand Name: 1.3 MM SQUARE SCREWDRIVER
• Common Device Name: SCREWDRIVER
• 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: 21558863
• Report Number: 0001825034-2025-00615
• Device Sequence Number: 9127426
• Product Code: HXX
• UDI-Device Identifier: 00887868435799
• UDI-Public: (01)00887868435799(11)210819(10)201003
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2025

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: 231218012
• Device Lot Number: 201003
• 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: 03/04/2025
• Supplement Date Received by Manufacturer: 07/14/2025
• Initial Report FDA Received Date: 03/10/2025
• Supplement Report FDA Received Date: 08/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2021
• 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
• Patient Sex: Unknown