DEPUY SYNTHES POWER TOOLS COLIBRI; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
|
Back to Search Results |
|
Catalog Number 532.001 |
Device Problems
Defective Device (2588); Protective Measures Problem (3015)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).(b)(6).The device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.Reliability engineering evaluated the device and 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 report will be submitted accordingly.
|
|
Event Description
|
It was reported by (b)(6) that during service and evaluation, it was observed that the small battery drive device control unit was not functioning and defective.It was also noted that the device failed pre-repair diagnostic tests for attachment coupling assessment and function of the off/osc/on switch mode.It was noted in the service order "for repair-sets temporarily out." 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 this 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
|
|
|