MAUDE Adverse Event Report: ARTHREX, INC. AUGMENTED REAMER DRIVE SHAFT, LOCKING; ORTHOPEDIC MANUAL SURG INSTR

Model Number	AUGMENTED REAMER DRIVE SHAFT, LOCKING
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On 5-may-2026, it was reported by a sales representative via (b)(4) that an ar-9676t drive shaft's locking pin fell off.Issue discovered during a case, device swapped, and case completed with no patient effect.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: AUGMENTED REAMER DRIVE SHAFT, LOCKING
• 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: 25285454
• Report Number: 1220246-2026-02999
• Device Sequence Number: 10059795
• Product Code: LXH
• UDI-Device Identifier: 00888867499058
• UDI-Public: (01)00888867499058(11)250402(10)128141-2
• 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): 07/14/2026

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: AUGMENTED REAMER DRIVE SHAFT, LOCKING
• Device Catalogue Number: AR-9676T
• Device Lot Number: 128141-2
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 05/05/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2026
• Supplement Date Received by Manufacturer: 07/01/2026
• Initial Report FDA Received Date: 05/26/2026
• Supplement Report FDA Received Date: 07/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/02/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown