DEPUY SYNTHES PRODUCTS LLC KINCISE CUP-ADAPTER-PINNACLE STRAIGHT; MOTOR, SURGICAL INSTRUMENT, AC-POWERED
|
Back to Search Results |
|
Catalog Number 1011-01-101 |
Device Problem
Material Twisted/Bent (2981)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 07/29/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If additional information should become available, a supplemental medwatch report will be sent accordingly.
|
|
Event Description
|
It was reported that during an unspecified surgical procedure, it was observed that the adapter device threads were bent and the cup was unable to thread the handle.There was an unknown amount of delay to the surgical procedure.It was unknown if a spare device was available for use.There was patient involvement.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
|
|
Manufacturer Narrative
|
The actual device was returned for evaluation.Quality engineering evaluated the device and it was determined that the device threads were bent and the cup would not thread the handle.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to improper device use which is user error.A device history review was performed, and no non-conformances were detected related to the reported condition.If additional information should become available, a supplemental medwatch will be submitted accordingly.
|
|
Manufacturer Narrative
|
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.It was documented in the initial medwatch that the date of manufacture was unknown.The date has been updated to may 21, 2019.The actual device has been returned and is currently pending evaluation.Once the investigation has been completed, a supplemental medwatch report will be submitted accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Search Alerts/Recalls
|
|
|