SYNTHES OBERDORF ELECTRIC PEN DRIVE 60,000 RPM; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
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Catalog Number 05.001.010 |
Device Problems
Difficult or Delayed Activation (2577); Device Operates Differently Than Expected (2913)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 09/29/2014 |
Event Type
malfunction
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Event Description
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It was reported that during training, it was observed that the electric pen drive device did not spin correctly and sputtered when activated.The event did not occur during surgery.It was reported that the device was only used for training.There were no delays to a planned surgical procedure.A spare device was not available for use.There was no patient involvement reported.There were no reports of injuries, medical intervention or prolonged hospitalization.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 actual device was returned for evaluation.Reliability engineering evaluated the device and the reported condition was not confirmed.Therefore, an assignable root cause was not determined.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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