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
Detachment of Device or Device Component (2907)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 01/01/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
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.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 (b)(6) that the black plate and washer of the recon sagittal saw device fell out.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 a surgical procedure or if a spare device was available for use.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of the event was unknown.However, it was reported that the event occurred in 2020.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 thrust disk had broken off from the expansion coupling, and the device failed the check coupling screw of the saw blade coupling.It was further observed that the device experienced a leak tightness test failure and the thread saw blade coupling was damaged.It was further determined that the device failed pretest for general condition, leakage test using bubble emission technique and check coupling screw of saw blade coupling.Therefore, the reported condition was confirmed.The assignable root cause was determined to be traced to user, which is user error.
|
|
Search Alerts/Recalls
|
|
|