MAUDE Adverse Event Report: ARTHREX, INC. AVL ANGLED REAMER SLEEVE ASSEMBLY, 25; ORTHOPEDIC MANUAL SURG INSTR

Model Number	AVL ANGLED REAMER SLEEVE ASSEMBLY, 25
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.Complaint not confirmed.Upon visual inspection, markings were noted on the distal end of the device.The devices were not returned assembled together.No problem found.
Event or Problem Description
On (b)(6) 2021, it was reported by a sales representative via sems that an ar-9597-20 (line #1) reamer sleeve and an ar-9676 (line #2)reamer shaft are welded together.This was discovered during a procedure, after a few seconds of reaming the two bonded together so they were moving as one piece and not independently.A second ar-9676 (line #3) was opened to finish the case and then proceeded to do the same thing.

• Brand Name: AVL ANGLED REAMER SLEEVE ASSEMBLY, 25
• 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: 19563839
• Report Number: 1220246-2024-06033
• Device Sequence Number: 15228209
• Product Code: LXH
• UDI-Device Identifier: 00888867350045
• UDI-Public: 00888867350045
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Report Date (Section B): 06/18/2024

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 ANGLED REAMER SLEEVE ASSEMBLY, 25
• Device Catalogue Number: AR-9297-25
• Device Lot Number: 052043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2021
• Initial Report FDA Received Date: 06/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/18/2021
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown