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 Codes	Fitting Problem (2183); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2025
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 03/14/2025, it was reported by a facility representative via (b)(4) that an ar-9297-15 avl angled reamer sleeve assembly inner shaft will no longer fit.No added time or adverse event occurred.The case was completed with a second driver from the set.This was discovered during a case with no patient affected.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint allegation is confirmed.One unpackaged ar-9297-15 univers vaultlock® augmented glenoid angled reamer sleeve was received for investigation.Visual evaluation of the returned device noted superficial wear and tear to the device with scratches, faded laser markings and discoloration observed.It was further noted that the device had striations along the inner diameter and collar of the device.The most likely cause for the reported failure can be attributed to overstressing a device that is damaged naturally and inevitably as a result of normal wear or aging from repeated usage/reprocessing.Refer to investigation photos.

• 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: 21764680
• Report Number: 1220246-2025-01205
• Device Sequence Number: 18315942
• Product Code: LXH
• UDI-Device Identifier: 00888867350038
• UDI-Public: 00888867350038
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2025

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2025
• Supplement Date Received by Manufacturer: 09/04/2025
• Initial Report FDA Received Date: 04/03/2025
• Supplement Report FDA Received Date: 09/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown