Catalog Number 234-200-200 |
Device Problems
Break (1069); Detachment Of Device Component (1104)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 09/21/2015 |
Event Type
malfunction
|
Manufacturer Narrative
|
Additional information will be provided once the investigation has been completed.The device manufacture date is not known at this time.However, should it become available it will be provided in future reports.
|
|
Event Description
|
It was reported that the micro fracture drill allegedly broke during the procedure.During use the solid tip broke off the flexible spring into the hip.The surgeon used graspers to remove the pieces.All pieces were successfully removed.No further drilling was required and the case was completed using a different instrument.
|
|
Manufacturer Narrative
|
"the reported device was not received for investigation; therefore the reported failure cannot be confirmed.The complaint will be closed without a detailed investigation report and based on probable root cause.In the event that the device is received, the complaint will be reopened, a full evaluation will be conducted, and the investigation will be updated with the new results.Probable root cause for the reported failure involving this device could have been caused by: "design: stackup issue between drill/guide, coil too stiff.Process: drill manufactured out of specification, drill guide/snap caps manufactured out of specification.Application: excessive force on drill guide bends shaft, not running drill when removing bit from bone".The product was not returned for investigation therefore the reported failure mode was not confirmed.The failure mode will be monitored for future reoccurrence.
|
|
Event Description
|
It was reported that the micro fracture drill allegedly broke during the procedure.During use the solid tip broke off the flexible spring into the hip.The surgeon used graspers to remove the pieces.All pieces were successfully removed.No further drilling was required and the case was completed using a different instrument.
|
|
Search Alerts/Recalls
|