DEPUY SYNTHES PRODUCTS LLC RECON SAGITTAL SAW WITH KEY FOR TRS; MOTOR, SURGICAL INSTRUMENT, AC-POWERED
|
Back to Search Results |
|
Catalog Number 05.001.240 |
Device Problem
Overheating of Device (1437)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 05/17/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
(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 during an unspecified surgical procedure the saw attachment device was overheating and stopped working.It was reported that there were no delays to the surgical procedure, and a spare device was used to complete the surgery.There was patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.All available has been disclosed.If additional information were to 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.This actual device was returned for evaluation.During repair it was determined that the device housing was deformed and bent.It was also determined that the device failed pre-test for check roundness of the housing.The assignable root cause was determined to be due to improper device maintenance.If additional information should become available, a supplemental medwatch will be submitted accordingly.
|
|
Search Alerts/Recalls
|
|
|