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 Fragmentation (1261)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 12/16/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).The device manufacture date was unknown.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 had a broken shaft at the t-handle junction.It was reported that there were no delays in the surgical procedure.It was not reported whether a spare device was available for use.There was patient involvement.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 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.The actual device was returned for evaluation.Quality engineering evaluated the device and it was determined that the device t-handle was broken in three pieces.It was further determined that the device was most likely side loaded when used with the impactor which is not what the device was designed for, or has been dropped.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to use error.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.Corrected data: d4: the udi was reported as (b)(4) in the initial report and has been updated to: udi: (b)(4).H4: the device manufacture date was documented as unknown in the initial report.It has been updated to (b)(4) 2018.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Search Alerts/Recalls
|
|
|