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	Device Embedded In Tissue or Plaque (3165)
Date of Event	09/10/2018
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 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 rtsa procedure, the peripheral locking screw, ar-9145-36, broke during insertion into the glenoid baseplate.What was left of the screw in the glenoid was left in order to not fracture the glenoid.The broken piece was secured in the baseplate.
Additional Manufacturer Narrative
Complaint confirmed.Visual evaluation of the returned ar-9145-36 revealed that the device had sheared off at the second, proximal thread prior to receipt for investigation.The most likely cause of this event is not implanting the screw coaxial to the hole, or bending/prying/leveraging the screw 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: 7943045
• Report Number: 1220246-2018-00691
• Device Sequence Number: 857061
• Product Code: PHX
• UDI-Device Identifier: 00888867057739
• UDI-Public: 00888867057739
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K142863
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2018

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: 04/30/2023
• Device Model Number: UNI GLENOID-PERIPHERAL LOCK SCRW
• Device Catalogue Number: AR-9145-36
• Device Lot Number: 18.00132
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2018
• Initial Date Received by Manufacturer: 09/17/2018
• Supplement Date Received by Manufacturer: 09/17/2018
• Initial Report FDA Received Date: 10/08/2018
• Supplement Report FDA Received Date: 10/26/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other