MAUDE Adverse Event Report: ARTHREX, INC. UNIVERSAL GLENOID T15 DRIVER LONG; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Model Number UNIVERSAL GLENOID T15 DRIVER LONG

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem Insufficient Information (4580)

Event Date 07/02/2021

Event Type  malfunction  

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.If the device becomes available for evaluation, a follow-up report will be submitted.

Event Description

It was reported that during a reverse total shoulder arthroplasty, while the surgeon was attempting to unscrew the suture cup from the reverse stem after he had mated the two implants.The surgeon realized that the 135 suture cup crease was not aligned properly with the stem lip.While attempting to unscrew, the tip of the ar-9202-t15, driver broke off into the screw of the suture cup.The surgeon was unable to remove the tip from the implant so they opened another suture cup and stem and used a t15 modular driver with ratcheting handle to complete the case.

Manufacturer Narrative

Complaint confirmed.Visual evaluation showed the tip was broken and twisted.The most likely cause(s) of this type of event include continually applying torque when the implant is not properly aligned and/or fully seated.

• Brand Name: UNIVERSAL GLENOID T15 DRIVER LONG
• Type of Device: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 12231496
• MDR Text Key: 265781075
• Report Number: 1220246-2021-03427
• Device Sequence Number: 1
• Product Code: MDM
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 10/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNIVERSAL GLENOID T15 DRIVER LONG
• Device Catalogue Number: AR-9202-T15H
• Device Lot Number: 250130900
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/06/2021
• Initial Date FDA Received: 07/27/2021
• Supplement Dates Manufacturer Received: 07/06/2021
• Supplement Dates FDA Received: 10/26/2021
• Patient Sequence Number: 1