DEPUY SYNTHES POWER TOOLS SMALL BATTERY DRIVE (COLIBRI); INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
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Catalog Number 532.001 |
Device Problems
Difficult or Delayed Activation (2577); Noise, Audible (3273)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Event Description
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It was reported from germany that during an unspecified surgical procedure, it was discovered that small battery drive device could not be started immediately.It was further reported that the device ran with a load unusual noise.There were no delays to the planned surgical procedure.It was unknown if a spare device was available for use.There was patient involvement reported.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date the event was unknown.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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(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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Manufacturer Narrative
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The actual device was returned for evaluation.Reliability engineering evaluated the device and observed that the control unit was not functioning and was defective.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to wear from normal use and servicing.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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