MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CEPHALOMEDULLARY FLEXIBLE CAPTURED SET SCREW DRIVER STANDARD 3.5 MM HEX; TRAUMA INSTRUMENT

Catalog Number	00249003507
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/05/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).G2: canada.H3: product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the femur was reamed and prepared for the nail as normal.The nail was inserted and guide wire removed.When reaming for the lag screw the tip of the drill fractured off and remained in the patient.The lag screw was inserted as per normal and was not affected.Attempts have been made and there is no further information at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d10, g3, g6, h2, h3, h6, h10, h11.D10: cephalomedullary lag screw reamer long 3.2 mm i.D.Cat# 00249003244 lot# 63921047.The flexible screwdriver has scratches on the connecting end of the device.The hex feature at the distal end of the screwdriver is also damaged.The screwdriver has fractured in the flexible area of the device.Checked 2 of the product identifiers and both were conforming to the print.Unable to check the overall length of the device as it has fractured into 2 pieces.This device has a possible field age of 2+ years.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.The reported event is confirmed with returned devices.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: CEPHALOMEDULLARY FLEXIBLE CAPTURED SET SCREW DRIVER STANDARD 3.5 MM HEX
• Common Device Name: TRAUMA INSTRUMENT
• 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: 21345750
• Report Number: 0001822565-2025-00303
• Device Sequence Number: 12999391
• Product Code: HSB
• UDI-Device Identifier: 00889024063631
• UDI-Public: (01)00889024063631(10)65383956
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K091566
• 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
• Report Date (Section B): 03/14/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 00249003507
• Device Lot Number: 65383956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2025
• 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: 01/14/2025
• Supplement Date Received by Manufacturer: 02/26/2025
• Initial Report FDA Received Date: 02/10/2025
• Supplement Report FDA Received Date: 03/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female