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Catalog Number 530.710 |
Device Problems
Physical Resistance/Sticking (4012); Complete Loss of Power (4015)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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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 sticky trigger identified during service and evaluation was confirmed.The assignable root cause was determined to be traced to user, which is user error.(b)(4).
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Event Description
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It was reported by netherlands that during service and evaluation, it was determined that the trigger of the battery oscillator device was sticky.It was further observed that the device had component and contact damage, would not run, and a worn motor.It was further determined that the device failed pretest for general condition, check for sticky trigger, check function of device and check oscillation frequency with frequency meter.It was noted in the service order that the device did not work at all.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, a supplemental medwatch will be submitted accordingly.
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Search Alerts/Recalls
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