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

Model Number	AUGMENTED REAMER DRIVE SHAFT, LOCKING
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 20-feb-2026, it was reported by a sales representative via (b)(4) that an ar-9676t augmented reamer drive shaft got bound up with an ar-9597-10 reamer sleeve and an ar-9597-20 reamer sleeve during reaming.Additional information provided 3-mar-2026: case was able to be completed with older inner reamer shafts and old reamer blades available, and the inner and outer sheath hadn't completely cold welded together.No other patient effects, a few minute delay to swap out devices.

• Brand Name: AUGMENTED REAMER DRIVE SHAFT, LOCKING
• Common Device Name: MANUAL INSTR, GENERAL SURGICAL
• 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: 24647578
• Report Number: 1220246-2026-01546
• Device Sequence Number: 9918575
• Product Code: LXH
• UDI-Device Identifier: 00888867499058
• UDI-Public: 00888867499058
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 07/08/2026

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
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2026
• Supplement Date Received by Manufacturer: 07/06/2026
• Initial Report FDA Received Date: 03/20/2026
• Supplement Report FDA Received Date: 07/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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