MAUDE Adverse Event Report: ARTHREX, INC. AVL PRIMARY REAMER, MODULAR, LARGE; ORTHOPEDIC MANUAL SURG INSTR

Model Number	AVL PRIMARY REAMER, MODULAR, LARGE
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 09/17/2024, a sales representative reported via sems-06665108 that an ar-9230ag univers vaultlock augmented glenoid primary reamer was very dull and not effectively reaming the bone.Nothing broke inside the patient.Another vlk tray was opened to use another reamer to complete the case.This was discovered during a total shoulder procedure on (b)(6) 2024, with no reported 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 confirmed.Visual evaluation noted that the cutting edges were chipped and strong abrasion marks around the shaft of the univers vaultlock® augmented glenoid primary reamer, large.Functional testing was not performed due to the damage to the device.The most likely cause of the reported failure can be attributed to wear and tear.

• Brand Name: AVL PRIMARY REAMER, MODULAR, LARGE
• 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: 20294611
• Report Number: 1220246-2024-07825
• Device Sequence Number: 18164342
• Product Code: LXH
• UDI-Device Identifier: 00888867350458
• UDI-Public: 00888867350458
• 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): 02/04/2025

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 PRIMARY REAMER, MODULAR, LARGE
• Device Catalogue Number: AR-9230AG
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2024
• Supplement Date Received by Manufacturer: 01/07/2025
• Initial Report FDA Received Date: 09/24/2024
• Supplement Report FDA Received Date: 02/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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