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

Model Number	AVL PRIMARY REAMER, MODULAR, SMALL
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On 07/11/2023, it was reported by a sales representative via sems that an ar-9228ag augmented glenoid primary reamer is worn.This was discovered during a case, with no patient effect reported.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint was confirmed.One unpackaged ar-9228ag serial/batch number (b)(6) was received for investigation.The returned devices were visually inspected, and it was noted nick on the cutting edges, the spring is coming out of the place.The most likely cause(s) for the reported failure is the wear and tear damage incurred over repeated usage.

• Brand Name: AVL PRIMARY REAMER, MODULAR, SMALL
• 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: emily shafer ; 8009337001
• MDR Report Key: 17486592
• Report Number: 1220246-2023-07459
• Device Sequence Number: 7246160
• Product Code: LXH
• UDI-Device Identifier: 00888867350434
• UDI-Public: 00888867350434
• 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): 11/04/2024

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, SMALL
• Device Catalogue Number: AR-9228AG
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2023
• Supplement Date Received by Manufacturer: 09/25/2023
• Initial Report FDA Received Date: 08/09/2023
• Supplement Report FDA Received Date: 11/04/2024
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown