DEPUY SYNTHES POWER TOOLS SMALL BATTERY DRIVE (COLIBRI); INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
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Catalog Number 532.003 |
Device Problem
Device Difficult to Setup or Prepare (1487)
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Patient Problem
No Information (3190)
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Event Type
malfunction
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Event Description
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It was reported from (b)(6) that the device does not load.It was not reported if the device was used in surgery, or if there was patient involvement.It was not reported if there were any delays in a surgical procedure or if a spare device was available.It was not reported if there were any injuries, medical intervention or prolonged hospitalization.The exact date of this 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).Additional narrative: the actual device was returned for evaluation.Reliability engineering evaluated the device and it was observed that the device does not function, therefore the reported condition was confirmed.An assessment was performed on the device which determined the root cause was due to normal wear.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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Search Alerts/Recalls
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