DEPUY SYNTHES PRODUCTS LLC BATTERY REAMER/DRILL FOR BPL II; MOTOR, SURGICAL INSTRUMENT, AC-POWERED
|
Back to Search Results |
|
Catalog Number 530.705 |
Device Problem
Physical Resistance/Sticking (4012)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 01/01/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.The device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.During repair, it was determined that the reported condition was confirmed.The assignable root cause was determined to be due to component failure from normal wear.Udi: (b)(4).
|
|
Event Description
|
It was reported from (b)(6) that during service and evaluation, it was determined that the battery reamer device moving parts did not move smoothly - trigger, and the trigger was sticky and hooked.It was further determined that the device failed pretest for check for sticky trigger.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of the event was unknown.However, it was reported that the event occurred in 2020.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
|
|
Search Alerts/Recalls
|
|
|