MAUDE Adverse Event Report: ARTHREX, INC. SOLID SCREWDRIVER, T6 HEXALOBE; ORTHOPEDIC MANUAL SURG INSTR

Model Number	SOLID SCREWDRIVER, T6 HEXALOBE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 09/26/2024, it was reported by a sales representative via (b)(4) that an ar-18800-05 solid screwdriver tip broke off inside of the screw head inside the patient.The case was not affected.This was discovered during a procedure on 09/19/2024, 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
Complaint is confirmed.Visual inspection identified that the drive geometry at the distal tip of the returned solid screwdriver, t6, had broken and twisted.No broken pieces were returned for investigation.Functional testing was not performed due to the damage to the device.The most likely cause is attributed to user error of the device due to over-torquing/over-engaging the driver within the screw head.

• Brand Name: SOLID SCREWDRIVER, T6 HEXALOBE
• Common Device Name: ORTHOPEDIC MANUAL SURG INSTR
• 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: 20472611
• Report Number: 1220246-2024-08186
• Device Sequence Number: 15354229
• Product Code: LXH
• UDI-Device Identifier: 00888867385658
• UDI-Public: (01)00888867385658(11)230908(10)1392333
• 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
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2025

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: SOLID SCREWDRIVER, T6 HEXALOBE
• Device Catalogue Number: AR-18800-05
• Device Lot Number: 1392333
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2024
• Supplement Date Received by Manufacturer: 12/31/2024
• Initial Report FDA Received Date: 10/17/2024
• Supplement Report FDA Received Date: 01/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2023
• 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