SYNTHES GMBH RECON SAGITTAL SAW WITH KEY FOR TRS; MOTOR, SURGICAL INSTRUMENT, AC-POWERED
|
Back to Search Results |
|
Catalog Number 05.001.240 |
Device Problem
Intermittent Loss of Power (4016)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 10/19/2022 |
Event Type
malfunction
|
Manufacturer Narrative
|
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for this medwatch, a supplemental medwatch report will be filed as appropriate.Additional narrative: as of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.Udi: (b)(4).
|
|
Event Description
|
It was reported from france that during an unspecified surgical procedure, it was discovered that the sagittal saw handpiece device stopped from time to time.It was not reported if there were any delays in the surgical procedure or if a spare device was available.There was patient involvement reported.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
|
|
Manufacturer Narrative
|
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for this medwatch, a supplemental medwatch report will be filed as appropriate.Device evaluation: the actual device was returned for evaluation.During repair, an evaluation was performed, and it was determined that the device had a worn gear, leak tightness test failure and insufficient/low power.It was further determined that the device failed pretest for leakage test using bubble emission technique and check oscillation frequency with frequency meter.Therefore, the reported condition was confirmed.The assignable root cause was determined to be traced to maintenance.
|
|
Search Alerts/Recalls
|
|
|