MAUDE Adverse Event Report: ARTHREX, INC. AVL ANGLED REAMER SLEEVE ASSEMBLY, 15; ORTHOPEDIC MANUAL SURG INSTR

Model Number	AVL ANGLED REAMER SLEEVE ASSEMBLY, 15
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2026
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 04-feb-2026, a facility representative reported via (b)(4) that when using the ar-9275t-l augmented vaultlock reamer, it would lock up and catch on an ar-9297-15 reamer sleeve.They never switched the actual disposable reamer head.The anatomic total shoulder procedure was completed successfully with no patient harm.

• Brand Name: AVL ANGLED REAMER SLEEVE ASSEMBLY, 15
• 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: 24401093
• Report Number: 1220246-2026-00695
• Device Sequence Number: 9905493
• Product Code: LXH
• UDI-Device Identifier: 00888867350038
• UDI-Public: (01)00888867350038(11)210826(10)052116
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 05/13/2026

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: AVL ANGLED REAMER SLEEVE ASSEMBLY, 15
• Device Catalogue Number: AR-9297-15
• Device Lot Number: 052116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Distributor Facility Aware Date: 02/04/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2026
• Supplement Date Received by Manufacturer: 05/12/2026
• Initial Report FDA Received Date: 02/20/2026
• Supplement Report FDA Received Date: 05/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown