DEPUY SYNTHES POWER TOOLS CAD II; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
|
Back to Search Results |
|
Catalog Number 511.701 |
Device Problems
Self-Activation or Keying (1557); Defective Device (2588); Device Operates Differently Than Expected (2913)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 10/18/2016 |
Event Type
malfunction
|
Manufacturer Narrative
|
Udi - (b)(4).Initial reporter's phone number: (b)(4).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 the compact air drive device had an undetermined malfunction.During service and evaluation, it was determined that the device was running by itself, and had a bearing defect.It was also noted that the device failed pre-repair diagnostic tests for air leak, and power with test bench.It was not reported if the device was used in surgery, or if there was patient involvement.It was not reported if there were any delays in a surgical procedure or if a spare device was available.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.
|
|
Search Alerts/Recalls
|
|
|