Model Number UNI GLENOID-PERIPHERAL LOCK SCRW |
Device Problems
Break (1069); Entrapment of Device (1212)
|
Patient Problem
Foreign Body In Patient (2687)
|
Event Date 12/09/2022 |
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
|
On 12/15/2022 it was reported by a sales representative by email that a ar-9145-48 universal glenoid locking screw broke when being driven into a glenoid.This was discovered during an eclipse tsa w/ convertible universal glenoid on (b)(6) 2022.The tip was removed, but the remainder of the screw was left in the patient.
|
|
Event Description
|
Additional information received 12/15/22: the procedure was completed by shaving down the tip of the superior broken screw on the universal baseplate that was impeding the inlay poly from seating.The central and inferior peripheral screws were implanted without issue.
|
|
Manufacturer Narrative
|
The complaint is confirmed based on the customer provided photo, which displays the distal end on the implant had broken and damaged threads.However, without the return of the device for physical evaluation, the most likely cause for the reported failure can be attributed to user error of the device due to excessive force, misaligned insertion and/or prying/leveraging the device during use.
|
|
Search Alerts/Recalls
|