SYNTHES GMBH OSCILLATING SAW ATTACHMENT II; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
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Catalog Number 511.801 |
Device Problems
Mechanical Jam (2983); 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 reported condition that the device was frozen/would not move, identified during service and evaluation was confirmed.The assignable root cause was determined to be due to component failure from wear.Udi: (b)(4).
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Event Description
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It was reported by (b)(6) that during service and evaluation, it was determined that the attachment device had a seized gear, worn seal and was frozen/would not move.It was further determined that the device failed pretest for check function in running mode and check the oscillation frequency with frequency meter.It was noted in the service order that the device did not work.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 available, a supplemental medwatch will be submitted accordingly.
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Search Alerts/Recalls
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