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Catalog Number 530.710 |
Device Problems
Unintended Movement (3026); 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 synthese, or its employees that the report constitutes an admission that the product, depuy synthese, 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 maintenance, which is improper maintenance.Udi: (b)(4).
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Event Description
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It was reported by germany that during service and evaluation, it was determined that the trigger of the battery oscillator device was sticky.It was further observed that the mode switch was stuck, the pins in the saw head locking mechanism were broken, and the bearing was worn.It was determined that the device would not run because the electrical control unit was damaged.It was further noted that the saw head position was not symmetrical.It was further determined that the device failed pretest for check positioning of saw head, check for sticky trigger, check function of device, check oscillation frequency with frequency meter and mode switch-test.It was noted in the service order that the during a check before surgery, it was discovered that the device did not start working and the head rotated freely.It was further reported that there were no delays to the surgical procedure and a spare device was available for use.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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