|
Model Number SCORPION-MULTIFIRE NEEDLE |
Device Problems
Break (1069); Entrapment of Device (1212)
|
Patient Problem
Foreign Body In Patient (2687)
|
Event Date 11/28/2022 |
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
|
It was reported by a sales representative via sems that a ar-13995n scorpion¿ needle tip broke off.This occurred on (b)(6) 2022 during a shoulder arthroscopy with labral repair when the surgeon was using the device to penetrate the graft the tip broke off, the surgeon stated the graft tissue was stretchy and believes it could have broken the tip off.Although attempts were made to retrieve the fragment, it was not successful the piece remains in the patient.
|
|
Search Alerts/Recalls
|
|
|