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

Model Number UNIVERS REVERS HUMERAL LINER IMPACTOR

Device Problem Defective Component (2292)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/18/2022

Event Type  malfunction  

Event Description

It was reported that during a shoulder prosthesis surgery the white cap of the device was defect.The thread couldn`t be screwed.No part of the device broke off.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with the same device.It was not necessary to switch the surgical technique or do a second surgery.Update 28-mar-2022: it was confirmed that the white cap of the device broke.

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.

Manufacturer Narrative

Complaint confirmed.Upon visual inspection it was found that the insert is missing.The cause of this event remains undetermined.

• Brand Name: UNIVERS REVERS HUMERAL LINER IMPACTOR
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 14075386
• MDR Text Key: 296780741
• Report Number: 1220246-2022-04730
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 00888867062184
• UDI-Public: 00888867062184
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 06/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNIVERS REVERS HUMERAL LINER IMPACTOR
• Device Catalogue Number: AR-9531
• Device Lot Number: 250140601
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2015
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1