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 Code	Unspecified Infection (1930)
Date of Event	12/12/2019
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 two peripheral screws of the prosthesis broke post op.It was further reported that the breakage was not the result of a trauma.Initial surgery was an inverse shoulder prosthesis, performed on (b)(6) 2019.Revision surgery was performed on (b)(6) 2019.All fragments have been removed during the revision surgery.During the revision, a spacer was implanted.No further information received.Update 29-june-2020: the central screw was intact.Batch numbers were provided.The device breakage was discovered by x-ray.All available x-rays have been provided to arthrex.Patient had reported to the surgeon that post op aftercare instructions were followed.Because of an infection, a cement spacer was implanted.It is expected that the total prosthetics will be returned.

• 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: 10279382
• Report Number: 1220246-2020-01950
• Device Sequence Number: 10935161
• Product Code: PHX
• UDI-Device Identifier: 00888867057746
• UDI-Public: 00888867057746
• 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,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/15/2020

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: 05/31/2022
• Device Model Number: UNI GLENOID-PERIPHERAL LOCK SCRW
• Device Catalogue Number: AR-9145-42
• Device Lot Number: 170005712
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2020
• Initial Report FDA Received Date: 07/15/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other