SYNTHES GMBH RECON SAGITTAL SAW WITH KEY FOR TRS; MOTOR, SURGICAL INSTRUMENT, AC-POWERED
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Catalog Number 05.001.240 |
Device Problems
Device-Device Incompatibility (2919); Unintended Movement (3026); Physical Resistance/Sticking (4012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/06/2022 |
Event Type
malfunction
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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 recon sagittal saw with key device thread saw blade coupling had a sticky trigger, leak tightness test failure, locking mechanism was stiff/stuck, would not run, could not engage attachment and was deformed/bent.It was further determined that the device failed pretest for leakage test using bubble emission technique, check coupling screw of saw blade coupling, check the saw blade coupling, check the saw head¿s locking mechanism, check for sticky trigger, check roundness of housing, check function of device and check oscillation frequency with frequency meter.It was noted in the service order that the blade lock no longer worked and spun continuously in a vacuum.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should 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.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, it was determined that the reported condition that the blade lock spun continuously in a vacuum was not confirmed.Therefore, an assignable root cause for the reported condition of loose saw head was not determined.However, during evaluation, it was determined that the device had a sticky trigger.The assignable root cause was determined to be traced to maintenance.Udi: (b)(4).
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