MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS REVERS TRIAL 36 +3; ORTHOPEDIC MANUAL SURG INSTR

Model Number UNIVERS REVERS TRIAL 36 +3

Device Problem Material Fragmentation (1261)

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

Event Date 10/16/2023

Event Type  malfunction  

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 Description

It was reported that during an univers revers shoulder prosthesis surgery the device produced debris.There was no harm for patient, operator or third party.The surgery was finished successfully and the same device was used anyway.It was not necessary to switch the surgical technique or do a second surgery.Update nroe 17-oct-2023: further information revealed that all broken-off pieces could be retrieved from the patient.

Manufacturer Narrative

Additional information: h6.Complaint is confirmed.Visual evaluation notices that the edges around the device were damaged, and one of the borders of the hole was broken.No broken pieces were returned for investigation.Functional testing was not performed due to the damage to the device.Functional testing was not performed due to the damage to the device.The most likely cause of this failure is attributed to wear and tear damage incurred over repeated usage.

• Brand Name: UNIVERS REVERS TRIAL 36 +3
• Type of Device: 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: emily shafer ; 8009337001
• MDR Report Key: 18072460
• MDR Text Key: 327378018
• Report Number: 1220246-2023-08560
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 00888867062146
• UDI-Public: 00888867062146
• 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: 01/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNIVERS REVERS TRIAL 36 +3
• Device Catalogue Number: AR-9530S-03
• Device Lot Number: 250120600
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1