MAUDE Adverse Event Report: ARTHREX, INC. UNI GLENOID-PERIPHERAL LOCK SCRW; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number	UNI GLENOID-PERIPHERAL LOCK SCRW
Health Effect - Clinical Codes	Failure of Implant (1924); Foreign Body In Patient (2687)
Date of Event	08/25/2020
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that during a universal glenoid procedure two ar-9145-42, uni glenoid peripheral locking screws (lot 18.00584) broke during insertion.Both screws broke from the head as the surgeon tried to retrieve them, small pieces kept breaking off.The surgeon proceeded to remove the central screw along with the base plate and left about half to a quarter of the screw in the patient as the portion could not be retrieved.The surgeon had to change the technique from a universal glenoid to a reverse modular glenoid.In order to make the change the surgeon also had to remove the following devices (quantity one each) which had just been implanted: ar-9165-25 universal glenoid central screw (lot 18.01267), ar-9145-24 universal glenoid peripheral locking screw (lot 18.02031) and ar-9120-03 universal glenoid baseplate (lot 170014815).Patient bone quality was reported to be good and hard.The patient was a young male.Reporter states the surgeon used the proper implant technique with the proper drill bit.All screws were disposed of at time of procedure.Baseplate was kept to return for evaluation.

• Brand Name: UNI GLENOID-PERIPHERAL LOCK SCRW
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10515529
• Report Number: 1220246-2020-02144
• Device Sequence Number: 14366597
• Product Code: PHX
• UDI-Device Identifier: 00888867057746
• UDI-Public: 00888867057746
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K142863
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 09/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: UNI GLENOID-PERIPHERAL LOCK SCRW
• Device Catalogue Number: AR-9145-42
• Device Lot Number: 18.00584
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2020
• Initial Report FDA Received Date: 09/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other