MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS REVERS HUMERAL LINER IMPACTOR; MANUAL INSTR, GENERAL SURGICAL

Model Number	UNIVERS REVERS HUMERAL LINER IMPACTOR
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 01/31/2023, it was reported by a sales representative via sems that a ar-9531 humeral liner impactor broke.This occurred during a case, with no patient effect reported.No additional information provided.Additional information requested.Additional information provided 01/30/2023: the procedure performed was rsa on (b)(6) 2023.This was discovered during the implantation of humeral cup poly which is the last part of the case.The bone quality of the patient was good.No fragments broke inside of the patient.
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 allegation confirmed based on the photo provided by the reporter.Visual inspection revealed that the ar-9531 humeral liner impactor handle was broken.The most likely cause for the reported failure can be attributed to user error due to user-applied excessive mechanical forces.

• Brand Name: UNIVERS REVERS HUMERAL LINER IMPACTOR
• Common Device Name: MANUAL INSTR, GENERAL SURGICAL
• 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: 19498620
• Report Number: 1220246-2024-05397
• Device Sequence Number: 20810289
• Product Code: LXH
• UDI-Device Identifier: 00888867062184
• UDI-Public: 00888867062184
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 06/10/2024

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 LINER IMPACTOR
• Device Catalogue Number: AR-9531
• Device Lot Number: 052118
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2023
• Initial Report FDA Received Date: 06/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2021
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown