DEPUY SYNTHES PRODUCTS LLC BATTERY OSCILLATOR II FOR BPL II; MOTOR, SURGICAL INSTRUMENT, AC-POWERED
|
Back to Search Results |
|
Catalog Number 530.710 |
Device Problem
Unexpected Shutdown (4019)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 01/01/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
Concomitant med products and therapy dates: saw blade device, (b)(6) 2019.The actual device has been returned and is currently pending evaluation.Once the evaluation of the device has been completed, a supplemental medwatch report will be sent accordingly.Udi ¿ (b)(4).
|
|
Event Description
|
It was reported from (b)(6) that during an unspecified surgical procedure, the battery oscillator device stopped working when the blade came in contact with hard bone.It was noted that the blades movements stopped even when the motor was working.It was not reported if there were any delays in a surgical procedure or if a spare device was available.There was 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.Corrected data: d10: the date the device was returned to the manufacturer was reported as 4/30/19 in the initial report and has been updated to 4/18/19.This actual device was returned for evaluation.During repair it was determined that the the device had a worn bearing and failed pre-test for functional test.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to premature wear.If additional information should become available, a supplemental medwatch will be submitted accordingly.
|
|
Search Alerts/Recalls
|
|
|