|
Model Number DRIVER, T10 HEXALOBE |
Device Problem
Break (1069)
|
Patient Problem
Insufficient Information (4580)
|
Event Date 09/05/2023 |
Event Type
malfunction
|
Event Description
|
On 9/25/2023, an fda medwatch notification was received via email.A facility representative reported that an ar-8944dh t10 hexalobe driver tip broke off in a distal locking screw head.The tip was about 2mm, and it could not be removed from the head of the screw.This was discovered during a procedure on (b)(6) 2023.
|
|
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.
|
|
Search Alerts/Recalls
|
|
|