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 11/21/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
The actual device was returned for evaluation.During repair, an evaluation was performed and it was determined that the trigger of the device was not moving smoothly.Therefore, the reported condition that the device had an undetermined malfunction was confirmed.The assignable root cause was determined to be traced to user, which is user error.If additional information should become available, a supplemental medwatch report will be submitted accordingly.Udi: (b)(4).
|
|
Event Description
|
It was reported from the netherlands that during service and evaluation, it was determined that the trigger of the battery reamer/drill device was not moving smoothly, and the device had insufficient/low power.It was further determined that the device failed pretest for trigger test, check trigger and electric control unit (ecu) function, and check power at the motor with test bench.It was noted in the service order that the device had an undetermined malfunction.This event did not occur during surgery.There was no patient involvement.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 will be submitted accordingly.
|
|
Search Alerts/Recalls
|
|
|