DEPUY SYNTHES PRODUCTS LLC SMALL BATTERY DRIVE; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
|
Back to Search Results |
|
Catalog Number 532.001 |
Device Problem
Unexpected Shutdown (4019)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 01/01/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).
|
|
Event Description
|
It was reported from (b)(6) that during an educational laboratory it was observed that the engine of the small battery drive device suddenly failed.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of the event was not reported, however, it was reported that the event 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.Additional narrative: the actual device was returned for evaluation.During repair, an evaluation was performed and it was determined that the small battery drive device would not run, and the electrical control unit (ecu) was damaged.It was further determined that the device failed pretest for check the off/oscillation/on switch mode function.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to wear from normal use over time.If additional information should become available, a supplemental medwatch will be submitted accordingly.
|
|
Search Alerts/Recalls
|
|
|