MAUDE Adverse Event Report: ARTHREX, INC. T10 DRIVER, RETAINING; BONE FIXATION PLATE

Model Number	T10 DRIVER, RETAINING
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2024, it was reported by a sales representative via sems-06666422 that (b)(4)) of a 5042-100 t10 driver was used with a torque limiting handle, yet the threads were bent, so they did not properly grip the screws.No pieces broke inside the patient.The case was completed successfully using a t10 driver from the 2.7 mini frag set without issues.This was discovered during a procedure on (b)(6) 2024, with no reported patient harm.Additional information has been requested.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The most likely cause for the reported failure can be attributed to overstressing a device that is damaged naturally and inevitably as a result of normal wear or aging from repeated usage/reprocessing.

• Brand Name: T10 DRIVER, RETAINING
• Common Device Name: BONE FIXATION PLATE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 20332322
• Report Number: 1220246-2024-07895
• Device Sequence Number: 12763326
• Product Code: HRS
• UDI-Device Identifier: 00848665039320
• UDI-Public: 00848665039320
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K202489
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2025

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 Model Number: T10 DRIVER, RETAINING
• Device Catalogue Number: 5042-100
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2024
• Supplement Date Received by Manufacturer: 06/06/2025
• Initial Report FDA Received Date: 09/30/2024
• Supplement Report FDA Received Date: 06/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown