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 Inoperable (1663); Mechanical Jam (2983)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 07/10/2016 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).(b)(6).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If additional information should become available, a supplemental medwatch report will be sent accordingly.
|
|
Event Description
|
It was reported from (b)(6) that during an unspecified surgery, it was observed that the small battery drive device stopped functioning.According to the report, the trigger button on the device was jamming and getting stuck.There was no delay to the surgical procedure as an identical spare device was available for use to complete the procedure.There was patient involvement reported.There were no 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.
|
|
Manufacturer Narrative
|
The actual device was returned for evaluation.Reliability engineering evaluated the device and observed that the device was not functional, did not run, had sticky triggers, worn coupling head and had corrosion on internal components.Therefore, the reported condition was confirmed.The assignable root cause was determined to due to wear and failure to follow cleaning, sterilization and/or maintenance procedures per the directions for use.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Search Alerts/Recalls
|
|
|