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	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2023
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 (b)(6) 2023, it was reported by a sales representative via sems that an ar-9531 humeral liner impactor head fell off.This occurred during an rtsa on (b)(6) 2023 the head fell off due to the threads being stripped.There was no additional information provided.Additional information has been requested.Additional information was provided on (04/18/2023, it was reported that all fragments were retrieved from the patient.The case was completed, and there was no patient effect reported.
Additional Manufacturer Narrative
Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to misuse/mishandling due to damage to the device.

• 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: vik bajnath ; 8009337001
• MDR Report Key: 16906325
• Report Number: 1220246-2023-06706
• Device Sequence Number: 6819524
• Product Code: LXH
• UDI-Device Identifier: 00888867062184
• UDI-Public: 00888867062184
• 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,Followup
• Report Date (Section B): 10/15/2024

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
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2023
• Supplement Date Received by Manufacturer: 10/07/2024
• Initial Report FDA Received Date: 05/10/2023
• Supplement Report FDA Received Date: 10/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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