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

Model Number	DRIVER SHAFT, T10 HEXALOBE, CANNULATED
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, it was reported by a sales representative via (b)(4) that an ar-8737-16 driver twisted up while the hcp was putting in the screws.A different driver was brought in to complete the case.No time was added to the case, and no additional anesthesia was administered, no patient harm.
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.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 for the reported failure can be attributed to improper bone prep; misaligned insertion; prying/leveraging the device during insertion.

• Brand Name: DRIVER SHAFT, T10 HEXALOBE, CANNULATED
• 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: 23304456
• Report Number: 1220246-2025-04630
• Device Sequence Number: 16000791
• Product Code: LXH
• UDI-Device Identifier: 00888867046115
• UDI-Public: (01)00888867046115(10)6791126
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 02/02/2026

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 SHAFT, T10 HEXALOBE, CANNULATED
• Device Catalogue Number: AR-8737-16
• Device Lot Number: 6791126
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 10/06/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2025
• Supplement Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 02/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown