|
Catalog Number 530.710 |
Device Problems
Physical Resistance/Sticking (4012); Complete Loss of Power (4015)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Type
malfunction
|
Event Description
|
It was reported from the netherlands that during service and evaluation, it was determined that the battery oscillator device would not run, had a worn motor, contact damage, mode switch resistance was too low, fluid ingress, worn swing fork and sticky trigger.It was further determined that the device failed pretest for general condition, check for sticky trigger, check function of the device, check the oscillation frequency with the frequency meter and mode switch test.It was noted in the service order that the device had an unspecified malfunction.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of the event was unknown.All available information has been disclosed.If additional information should become available, an additional 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.The actual device was returned for evaluation.During repair, an evaluation was performed and it was determined that the reported condition was confirmed.The assignable root cause was determined to be due to component wear.Udi: (b)(4).
|
|
Search Alerts/Recalls
|
|
|