MAUDE Adverse Event Report: ARTHREX, INC. AUGMENTED MGS REAMER, LOCKING, S; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	AUGMENTED MGS REAMER, LOCKING, S
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 10/30/2025, an arthrex employee reported via (b)(4) that (qty.2) ar-9675t-s augmented small locking reamers froze up within the orientation sleeve.They were discovered during a case with 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
-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.

• Brand Name: AUGMENTED MGS REAMER, LOCKING, S
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 23569040
• Report Number: 1220246-2025-05087
• Device Sequence Number: 13226414
• Product Code: LXH
• UDI-Device Identifier: 00888867499034
• UDI-Public: (01)00888867499034(11)250228(17)300131(10)15397430
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 03/16/2026

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 MGS REAMER, LOCKING, S
• Device Catalogue Number: AR-9675T-S
• Device Lot Number: 15397430
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 10/30/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2025
• Supplement Date Received by Manufacturer: 03/13/2026
• Initial Report FDA Received Date: 11/17/2025
• Supplement Report FDA Received Date: 03/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/28/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown