DEPUY SYNTHES POWER TOOLS 3MM FLUTED MATCHSTICK, 15CM; DRILLS, BURRS, TREPHINES AND ACCESSORIES (SIMPLE, POWERED)
|
Back to Search Results |
|
Catalog Number UNK - DRILL BIT |
Device Problems
Bent (1059); Sticking (1597)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 11/18/2015 |
Event Type
malfunction
|
Manufacturer Narrative
|
As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Event Description
|
This is report 2 of 2 for the same event.It was reported that during a spine surgical procedure, it was discovered that the bearing sleeve attachment device used along with an unknown burr device was stuck inside angle driver attachment device.It was further reported that the bearing sleeve attachment was bent.According to the reporter, there was no fracture to the burr.There were no delays to the surgical procedure and spare devices were available for use.The surgery was successfully completed.There was patient involvement reported.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of the event was not reported.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
|
|
Manufacturer Narrative
|
The initial report stated that the event report was 2 of 2 for the same event.Upon complaint review, it has been determined that this is report 2 of 3 for the same event to reflect the correct number of report sequence.If information is obtained that was not available, a follow-up medwatch will be filed as appropriate.
|
|
Manufacturer Narrative
|
Product code was unknown in the initial report.It has been updated as ma15-8nsd2: brand name, common device name, device product code and 510(k) have been updated accordingly.Serial/lot number was unknown in the initial report.It has been updated as (b)(4).It was documented as unknown in the initial report.The device manufacture date has been updated as sep 16, 2015.(b)(4).Device evaluation: the actual device was returned for evaluation.Reliability engineering evaluated the device and observed that the device was fully functioning and met specification (no issues found).Therefore, the reported condition was not confirmed.An assignable root cause was not determined.If additional information should become available, a supplemental medwatch report will be sent accordingly.
|
|
Search Alerts/Recalls
|
|
|