DEPUY SYNTHES POWER TOOLS SMALL BATTERY DRIVE; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
|
Back to Search Results |
|
Catalog Number 532.010 |
Device Problems
Sticking (1597); Device Stops Intermittently (1599)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 01/22/2016 |
Event Type
malfunction
|
Manufacturer Narrative
|
The actual device was returned for evaluation.Reliability engineering evaluated the device and the reported condition was not confirmed.Therefore, an assignable root cause was not determined.However, during evaluation, it was observed that the device did not run, the triggers were sticking and the coupling head was worn.It was further determined that the electric motor was damaged/corrosion, the bearings (rough rotation), the seals were damaged and there was corrosion on the internal gear components.It was further determined that the trigger components were damaged.The assignable root cause was determined to be due to component wear.If information is obtained that was not available, a follow-up medwatch will be filed as appropriate.
|
|
Event Description
|
It was reported that there was a possible short in the small battery drive device and the device ran intermittently.The reporter indicated that the event was discovered by a central sterile personnel.During in-house engineering evaluation, it was observed that the triggers were sticking.The event was not reported to have occurred during surgery.It was not reported if there were any delays in the surgical procedure or if a spare device was available for use.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
|
|
Search Alerts/Recalls
|
|
|