MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS REVERS HUMERAL CUP REAMER -M/39; ORTHOPEDIC MANUAL SURG INSTR

Model Number	UNIVERS REVERS HUMERAL CUP REAMER -M/39
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2022
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 is confirmed.One unpackaged ar-9508-39 serial/batch number ar07770301 was received for investigation.Functional test with ar-9510rg-r, batch# 051549, found that the device and the matting work as required.Visual evaluation found heavy lines inside the diameter of the humeral cup, as well as many burrs were observed on the holes of the cup.The most likely cause for the reported failure can be attributed to user error of the device due to excessive forces applied during use.
Event or Problem Description
On 09/30/2022, it was reported by a sales representative via sems that the surgeon had difficulty inserting the ar-9508-39 reamer over the 135 +2 right reamer guide pin.When using the reamer on power, it appeared to catch and torque on the guide pin.A new tray was opened and another ar-9508-39 was used to complete the case.Post-surgery inspection appears to show some wear marks on the internal portion of the 39mm reamer.

• Brand Name: UNIVERS REVERS HUMERAL CUP REAMER -M/39
• 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: 19476083
• Report Number: 1220246-2024-05033
• Device Sequence Number: 7072475
• Product Code: LXH
• UDI-Device Identifier: 00888867061552
• UDI-Public: 00888867061552
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 06/06/2024

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: UNIVERS REVERS HUMERAL CUP REAMER -M/39
• Device Catalogue Number: AR-9508-39
• Device Lot Number: AR07770301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2022
• 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