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
Difficult to Remove (1528)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 07/08/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).Concomitant device and therapy dates: adapter device, (b)(6) 2019.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
|
This is event 2 of 2 of the same event.It was reported that during an unspecified surgical procedure, it was observed that two adapter devices would not unscrew from the cup in-vivo use.It was reported that there were no delays to the surgical procedure.It was not reported 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
|
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 reported condition was not confirmed.During evaluation, it was determined that the device operated as intended however, medical debris was observed on the threads.The assignable root cause was determined to be due to improper cleaning practices.Additionally, a review of the device history 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.Corrected data: the manufacturer location was documented as palm beach gardens in the initial report.The location has been updated to techtronic industries.Contact office name/address has been updated accordingly to reflect the correct manufacturing facility.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
|
|
|