MAUDE Adverse Event Report: ARTHREX, INC. ARTHREX T10 MINI STANDARD; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	AR-8737-38
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Screwdriver tip broke off during surgical procedure.

• Brand Name: ARTHREX T10 MINI STANDARD
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.
• MDR Report Key: 25241373
• Report Number: MW5188525
• Device Sequence Number: 16085689
• Product Code: LXH
• UDI-Device Identifier: 00888867127166
• UDI-Public: (01)00888867127166
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): Y
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 05/18/2026

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: AR-8737-38
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/20/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 95 KG
• Patient Race: Asian