DEPUY SYNTHES POWER TOOLS 6.5CM ADULT CRANI ATTACHMT; MOTOR, DRILL, ELECTRIC - CRANIOTOME
|
Back to Search Results |
|
Catalog Number CRANI-A |
Device Problems
Corroded (1131); Naturally Worn (2988)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Type
malfunction
|
Manufacturer Narrative
|
Additional narrative: (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.It was also noted that the device had worn out bearings causing the device to fail cutter insertion test.It was determined that this was consistent with normal wear over time.It was further determined that the device had a drilled neuro tip which was consistent with failure to follow the directions for use.It was determined that when the burr device was improperly loaded into the attachment device and then installed onto the drill device, the burr did not seat properly in the locking chamber.It was determined that the attachment device could be forced into position which placed the distal tip of the burr in compression.At this point, the tip of the burr was in direct contact with the neuro tip of the attachment.When the drill was started, the burr drilled into or through the neuro tip.The assignable root cause was determined to be due to user error and normal wear.If additional information should become available, a supplemental medwatch report will be sent accordingly.
|
|
Event Description
|
It was reported by (b)(6) that the craniotome device had an undetermined malfunction.During service and evaluation, it was observed that the device failed cutter insertion test due to worn out bearings.It was also noted that the device had a drilled neuro tip, corrosion and failed cutter insertion test.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
|
|
|