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); Naturally Worn (2988)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).(b)(6).The actual device was returned for evaluation.Reliability engineering evaluated the device and the reported condition that the device was not working properly and working intermittently was not confirmed.Therefore, an assignable root cause was not determined.However, during evaluation it was observed the upper trigger was sticking, and the trigger components were worn.The assignable root cause of this condition was determined to be due to component wear from use over time, and improper cleaning and maintenance, which is user error/misuse/abuse.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
|
|
Event Description
|
It was reported from (b)(6) that the reverse mode of the small battery drive device was not working properly.It was noted to be working intermittently.During in-house engineering evaluation it was found that the upper trigger was sticking, and the trigger components were worn.It was not reported if this event occurred during a surgical procedure.The event was not reported to have occurred during surgery.It was not reported if there were any delays in a surgical procedure or if a spare device was available.It was not reported if there were any injuries, medical intervention or prolonged hospitalization.The exact date of the event was unknown.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
|
|
Search Alerts/Recalls
|
|
|