MAUDE Adverse Event Report: ARTHREX, INC. DRIVER, T10 HEXALOBE, BEVELED FT; ORTHOPEDIC MANUAL SURG INSTR

Model Number	DRIVER, T10 HEXALOBE, BEVELED FT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On 02-mar-2026, a facility representative reported via (b)(4) that an ar-8741-40 t10 beveled hexalobe driver shaft broke off into the head of the screw when inserting into patient during a metacarpal fx procedure.The broken piece was retrieved from the patient, and the case was completed successfully.Additional information was received on 04-mar-2026.The rep advised that the surgeon used a handle (ar-8700rh) attached to the driver shaft (ar-8741-40) to insert the screw by hand.They stated the surgeon used a 1.4mm guide wire (ar-8741-14), as well as a 2.9mm drill bit (ar-8741-25) to prep the bone for the insertion of the screw.The surgeon was not able to use the driver shaft (ar-8741-40) to remove the screw since the driver shaft broke off into the head of the screw (ar-8735bv-50).They were able to use instruments the hospital owned to retrieve the remaining pieces of the driver shaft out of the head of the screw.They then used a different driver shaft to remove the screw (ar-8735bv-50), they re-drilled with an ar-8741-25, and inserted an ar-8735bv-48, which was implanted using a different driver shaft.The surgeon used the 3.5mm beveled screws, implanted/explanted ar-8735bv-50, and implanted ar-8735bv-48.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: DRIVER, T10 HEXALOBE, BEVELED FT
• 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: 24650044
• Report Number: 1220246-2026-01567
• Device Sequence Number: 21334254
• Product Code: LXH
• UDI-Device Identifier: 00888867362635
• UDI-Public: (01)00888867362635(11)241203(10)1392447
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2026

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: DRIVER, T10 HEXALOBE, BEVELED FT
• Device Catalogue Number: AR-8741-40
• Device Lot Number: 1392447
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2026
• Supplement Date Received by Manufacturer: 06/12/2026
• Initial Report FDA Received Date: 03/20/2026
• Supplement Report FDA Received Date: 06/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/03/2024
• 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