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	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2025
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 10/31/2025, it was reported by a sales representative via (b)(4) that an ar-9675t-s reamer seized up during a case.While attached to the augment reamer shaft, and upon reaming the glenoid, the drill seized and failed to rotate any further.There were no implications for patient safety, and we were able to complete the case by opening another.
Additional Manufacturer Narrative
Complaint allegation is not confirmed.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 user error of the device due to misalignment insertion, incorrect assembly, and improper alignment of the device during insertion.Damage to the reamer can cause jamming when used with the mating part.

• 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: 23569925
• Report Number: 1220246-2025-05095
• Device Sequence Number: 15995581
• Product Code: LXH
• UDI-Device Identifier: 00888867499058
• UDI-Public: 00888867499058
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 03/06/2026

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
• Distributor Facility Aware Date: 10/31/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2025
• Supplement Date Received by Manufacturer: 03/02/2026
• Initial Report FDA Received Date: 11/17/2025
• Supplement Report FDA Received Date: 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown