DEPUY SYNTHES POWER TOOLS SAGITTAL SAW ATTACHMENT FOR PEN DRIVE; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
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Catalog Number 05.001.039 |
Device Problems
Device Inoperable (1663); Difficult to Open or Close (2921)
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Patient Problem
No Patient Involvement (2645)
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Event Date 06/01/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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It was reported that during a podiatric surgery, it was observed that the sagittal saw attachment device had an undetermined malfunction.It was further reported that the device would not open to allow the blade device to be attached.There was a twenty minute delay to the surgical procedure.A spare device was available to complete the surgery successfully.There was patient involvement reported.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of the event was unknown; however, the reporter stated that the event occurred during the month of (b)(6) 2016.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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Manufacturer Narrative
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The date of this report was documented as (b)(6) 2016 on the initial report.The correct date is (b)(6) 2016.The actual device was returned for evaluation.Reliability engineering evaluated the device and observed that the device was not functioning.It was further observed that the device did not rotate and was frozen.It was determined that there was an unknown substance found on the pinion cage and the planetary flange pin was bent.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to component wear.If information is obtained that was not available, a follow-up medwatch will be filed as appropriate.
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Search Alerts/Recalls
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