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

Model Number	AVL PRIMARY REAMER, MODULAR, MEDIUM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2024
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 05/10/2024, it was reported by a sales representative via (b)(4) that an ar-9229ag reamer was worn.This was discovered during a procedure with no patient harm.
Additional Manufacturer Narrative
Complaint allegation is confirmed.One unpackaged ar-9229ag serial/batch number (b)(6) was received for investigation.Visual evaluation found that the cutting blades are dull.The most likely reason for the reported failure is the wear and tear damage incurred over repeated usage.

• Brand Name: AVL PRIMARY REAMER, MODULAR, MEDIUM
• 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: 19479434
• Report Number: 1220246-2024-05113
• Device Sequence Number: 15200830
• Product Code: LXH
• UDI-Device Identifier: 00888867350441
• UDI-Public: 00888867350441
• 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): 08/29/2024

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, MEDIUM
• Device Catalogue Number: AR-9229AG
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 08/07/2024
• Initial Report FDA Received Date: 06/06/2024
• Supplement Report FDA Received Date: 08/29/2024
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown