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	Foreign Body In Patient (2687)
Date of Event	11/18/2019
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 during a tsa v rsa procedure, both 42mm peripheral locking screws, ar-9145-42 (lots: 170167213 and 18.00840) broke while being inserted into the baseplate.The screws had not yet engaged with the bushing on the baseplate when they broke.After the second screw broke, the decision was made to remove the entire baseplate.Upon doing so, it was discovered that the screws had broken deep enough within the bone.The surgeon decided to leave the distal tips in place and use an mgs implant.The remaining portion of the broken screws were deep enough within bone they did not interfere with mgs bony prep and standard surgical technique was carried out from that point forward.
Additional Manufacturer Narrative
Complaint confirmed, the screw broke in two.Most likely causes include misaligned insertion, improper bone prep, prying/leveraging the device during insertion.

• 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: 9443859
• Report Number: 1220246-2019-01469
• Device Sequence Number: 19576321
• Product Code: PHX
• UDI-Device Identifier: 00888867057746
• UDI-Public: 00888867057746
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Followup
• Report Date (Section B): 01/28/2020

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: 02/28/2023
• Device Model Number: UNI GLENOID-PERIPHERAL LOCK SCRW
• Device Catalogue Number: AR-9145-42
• Device Lot Number: 170167213
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/20/2019
• Supplement Date Received by Manufacturer: 11/20/2019
• Initial Report FDA Received Date: 12/10/2019
• Supplement Report FDA Received Date: 01/28/2020
• 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