DEPUY SYNTHES PRODUCTS LLC BATTERY HANDPIECE/MODULAR FOR TRS; MOTOR, SURGICAL INSTRUMENT, AC-POWERED
|
Back to Search Results |
|
Catalog Number 05.001.201 |
Device Problem
Physical Resistance/Sticking (4012)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 01/01/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
Udi: (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 from (b)(6) that the battery handpiece device buttons were not working properly.It was further reported that the triggers were sticky.It was not reported if the device was used in surgery, or if there was patient involvement.It was not reported if there were any delays in the surgical procedure, or if a spare device was available for use.It was not reported if there were any injuries, medical intervention or prolonged hospitalization.The exact date of this event was unknown but was noted to have occurred in 2019.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.During repair, an evaluation was performed and it was determined that the device would not run, trigger defective, worn bearing and failed pre-test for check history, check proper function of the triggers and free moving.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to component failure from normal wear.If additional information should become available, a supplemental medwatch will be submitted accordingly.
|
|
Search Alerts/Recalls
|
|
|