DEPUY SYNTHES POWER TOOLS 6.1CM ATTACHMENT, BLACK MAX; BUR, SURGICAL, GENERAL & PLASTIC SURGERY - ATTACHMENT
|
Back to Search Results |
|
Catalog Number B-SILVER |
Device Problem
Overheating of Device (1437)
|
Patient Problem
No Patient Involvement (2645)
|
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).(b)(6).This 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 further determined that the bearings were worn.The assignable root cause was determined to be due to wear from normal use and servicing.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
|
|
Event Description
|
It was reported from (b)(6) that the attachment device became hot.The event did not occur during surgery.There was no patient involvement reported.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
|
|
|