|
Catalog Number 530.710 |
Device Problem
Unintended System Motion (1430)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 02/06/2024 |
Event Type
malfunction
|
Event Description
|
It was reported from slovenia that the handpiece device turned on automatically when the battery was inserted.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.It was not reported if there were any injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental 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 the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 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).
|
|
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 the initial medwatch, a follow-up medwatch will be filed as appropriate.The actual device was returned for evaluation.During evaluation it was determined that the reported condition of the saw turned on automatically when the battery was inserted was not confirmed.Therefore, the assignable root cause was not determined.However, during evaluation, it was determined that the device would not run, had contact damage and failed pre-test for general condition, check function of the device and check the oscillation frequency with the frequency meter due to component wear.
|
|
Search Alerts/Recalls
|
|
|