MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS REVERS GLENO 39; SHOULDR PROSTH, REVERSE CONFIG

Model Number	UNIVERS REVERS GLENO 39
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); Foreign Body In Patient (2687)
Date of Event	02/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a surgery for the dislocated epiphyse the 135° screw broke off.No further information received.(b)(6) 2023, update dw.Further information was provided that the patient was treated with an arthrex implant in the past.The patient suffered an injury which resulted in an dislocated prosthesis cup.During the surgery on 24th february it was then noticed that screw which was placed at 135° was broken off.The surgeon then moved the cub and fixated the screw at 155° and the broken screw was not removed.
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.
Additional Manufacturer Narrative
Additional information: d9, g3, h6.It was reported that during a surgery for the dislocated epiphyse the 135° screw broke off.Further information were provided that the patient was treated with an arthrex implant in the past.The patient suffered an injury which resulted in an dislocated prosthesis cup.During the surgery on 24th february it was then noticed that screw which was placed at 135° was broken off.The surgeon then moved the cub and fixated the screw at 155° and the broken screw was not removed.Since the device was not received, an evaluation on the product could not be performed and the reported event cannot be verified.The most likely cause for the reported failure can be attributed to user error of the device due to excessive force being used during insertion of the screw.

• Brand Name: UNIVERS REVERS GLENO 39
• Common Device Name: SHOULDR PROSTH, REVERSE CONFIG
• 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: 16838020
• Report Number: 1220246-2023-06612
• Device Sequence Number: 12644194
• Product Code: PHX
• UDI-Device Identifier: 00888867061354
• UDI-Public: 00888867061354
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K142863
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2024

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 GLENO 39
• Device Catalogue Number: AR-9504M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2023
• Supplement Date Received by Manufacturer: 04/12/2024
• Initial Report FDA Received Date: 04/28/2023
• Supplement Report FDA Received Date: 05/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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