SYNTHES OBERDORF COLIBRI II; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
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Catalog Number 532.101 |
Device Problems
Defective Component (2292); Device Operates Differently Than Expected (2913); Mechanical Jam (2983); Power Problem (3010)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/24/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Udi: (b)(4).Reporter¿s complete name, address and phone number were not provided.The actual device was returned for evaluation.Reliability engineering evaluated the device and the reported condition was confirmed.The assignable root cause was determined to be due to device wear from normal use and servicing.If additional information should become available, a supplemental medwatch report will be sent accordingly.
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Event Description
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It was reported from (b)(6) that the small battery drive device had an unspecified malfunction.During an in-house engineering evaluation, it was observed that the motor was seized, jammed and heavymoving.It was also noted that the handpiece was not functioning due to a faulty motor.It was further noted that the device failed pre-test for off/oscillation/on switch mode function and power at the motor with test bench.It was not reported if the device was used in surgery, or if there was patient involvement reported.It was not reported if there were any delays in a scheduled surgical procedure or if a spare device was available for use.It was not reported if there were any 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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Search Alerts/Recalls
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