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

Model Number	SOLID SCREWDRIVER, T6 HEXALOBE
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On 04/22/2024, it was reported by a sales representative via (b)(4) that during a procedure multiple devices failed.During the procedure an ar-18800-04 driver shaft became twisted, an ar-18800-04 driver shaft snapped off, (2) ar-18800-03 driver shafts were twisted, an ar-18700-39 torque limiting adapter was not clicking when the torque was reached, a ar-18800-05 solid screwdriver was twisted, and a ar-18700-45 pointed reduction forceps would not close.No additional information was provided, and additional information has been asked.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.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: 19343543
• Report Number: 1220246-2024-03459
• Device Sequence Number: 8692985
• Product Code: LXH
• UDI-Device Identifier: 00888867385658
• UDI-Public: 00888867385658
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2025

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 Model Number: SOLID SCREWDRIVER, T6 HEXALOBE
• Device Catalogue Number: AR-18800-05
• Device Lot Number: 1392252
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2024
• Supplement Date Received by Manufacturer: 12/09/2024
• Initial Report FDA Received Date: 05/17/2024
• Supplement Report FDA Received Date: 01/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown