DEPUY SYNTHES PRODUCTS LLC BATTERY RECIPROCATOR II FOR BPL II; MOTOR, SURGICAL INSTRUMENT, AC-POWERED
|
Back to Search Results |
|
Catalog Number 530.715 |
Device Problem
Device Operates Differently Than Expected (2913)
|
Patient Problems
No Known Impact Or Consequence To Patient (2692); Not Applicable (3189)
|
Event Date 02/22/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Event Description
|
It was reported that during a total knee arthroplasty (tka) procedure, it was observed that the battery oscillator device failed to saw with the blade on when it was applied on to the bone.As a result, there was a three minute delay to the surgical procedure.A spare device was used to complete the procedure successfully.There was patient involvement.There were no 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.
|
|
Manufacturer Narrative
|
The actual device was returned for evaluation.Reliability engineering evaluated the device and determined that the motor was worn out, and had rough rotation, extreme vibration and worn o-rings.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to wear from normal use and servicing over time.If additional information should become available, a supplemental medwatch will be submitted accordingly.
|
|
Manufacturer Narrative
|
It was reported in error that the device was not returned for evaluation.Upon complaint review, it was determined that the actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Search Alerts/Recalls
|
|
|