DEPUY SYNTHES POWER TOOLS COLIBRI; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
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Catalog Number 532.001 |
Device Problems
Mechanical Problem (1384); Physical Resistance (2578); Mechanical Jam (2983)
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Patient Problem
No Information (3190)
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Event Type
malfunction
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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 that the device malfunctioned was confirmed.An assessment was performed and found that the motor had seized, jammed, and moving heavy.The assignable root cause was determined to be due to wear from normal use and servicing over time.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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Event Description
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It was reported from germany that the small battery drive device had an unspecified defect.During in-house engineering evaluation, it was observed that the motor had seized, jammed, and moving heavy.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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Upon further investigation it was found that the incorrect address of the account where the event occurred was inadvertently entered into the initial medwatch report.The correct address has been entered into this supplemental medwatch report.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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Search Alerts/Recalls
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