SYNTHES GMBH OSCILLATING SAW ATTACHMENT II; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
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Catalog Number 511.801 |
Device Problem
Mechanical Jam (2983)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/01/2022 |
Event Type
malfunction
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Event Description
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It was reported from germany that during service and evaluation, it was determined that the oscillating saw attachment device bearing seized and the device would not move.It was further determined that the device failed pretests for function in running mode and oscillation frequency with frequency meter.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 date of event was unknown but was known to have occurred in 2022.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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 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 traced to improper maintenance.Udi: (b)(4).
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Search Alerts/Recalls
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