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	07/09/2020
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 reverse total shoulder procedure, the head of the ar-9145-30, lot: 18.01718 screw broke screw while inserting into the baseplate.Using the screw driver ar-9545-t15-02 without the torque limiter the screw was fully seated before it broke.The head of the screw was removed and the remaining portion of the screw stayed in the patient.The baseplate and screw were left in the patient and the case was completed as desired fixation was achieved.
Additional Manufacturer Narrative
Complaint confirmed.Dimensional analysis using caliper concluded that only 9.05 mm of the ar-9145-30 screw remained, with the hex intact and a partial thread remaining.Visual inspection identified that the screw hex was noticeably damaged/rounded.Investigation of the concomitant ar-9545-t15-02 driver identified that the drive geometry had twisted during use with the ar-9145-30.It was noted that a torque indicating adapter was not used while the devices were functioned.Based on the aforementioned data and the observed state of the ar-9145-30 hex, this event is consistent with over-torquing during use, resulting in screw fracture.

• 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: 10309742
• Report Number: 1220246-2020-01970
• Device Sequence Number: 19094044
• Product Code: PHX
• UDI-Device Identifier: 00888867057722
• UDI-Public: 00888867057722
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2020

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: 12/31/2023
• Device Model Number: UNI GLENOID-PERIPHERAL LOCK SCRW
• Device Catalogue Number: AR-9145-30
• Device Lot Number: 18.01718
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/09/2020
• Supplement Date Received by Manufacturer: 07/09/2020
• Initial Report FDA Received Date: 07/22/2020
• Supplement Report FDA Received Date: 09/15/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other