DEPUY SYNTHES POWER TOOLS LARGE CHUCK WITH KEY DRILLING SPEED; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
|
Back to Search Results |
|
Catalog Number 05.001.253 |
Device Problem
Device Reprocessing Problem (1091)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 01/07/2016 |
Event Type
malfunction
|
Manufacturer Narrative
|
(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 information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Event Description
|
This is report 1 of 2 for the same event.It was reported from (b)(6) that after sterile processing, it was observed that a black sludge came out of the location where the body of the drive shaft of the large chuck device was connected to the body of the reduction drive device where there was a ring type component.According to the report, the devices had been through the cleaning process and had just finished the sterile process when the event was observed.It was further reported that the black sludge seemed too viscous and greasy to be lubricating oil.The reporter stated that heat might have pushed the sludge out and anything else inside the devices from use and cleaning.It was not reported if the devices were used in surgery or if there was patient involvement.It was not reported if there were any delays in the surgical procedure or if spare devices were available for use.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 report will be submitted accordingly.
|
|
Manufacturer Narrative
|
The actual device was returned for evaluation.Reliability engineering evaluated the device and the reported condition was not confirmed.Therefore, an assignable root cause was not determined.However, during evaluation, it was observed that the bearings were damaged (rough rotation), seals worn and the grease was dirty.The assignable root cause was due to component wear.If additional information should become available, a supplemental medwatch report will be sent accordingly.
|
|
Search Alerts/Recalls
|
|
|