SYNTHES OBERDORF SMALL BATTERY DRIVE II; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
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Catalog Number 532.110 |
Device Problems
Battery Problem (2885); Mechanics Altered (2984)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 07/01/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The actual device was returned for evaluation.Reliability engineering evaluated the device and the reported condition was confirmed.An assessment was performed on the device which found that the electronic control unit (ecu) was not functional and the electric motor had unusual vibration and was emitting a grinding noise.It was determined that the assignable root cause of this condition was due to component wear from normal use 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 that during pre-surgery testing, it was observed that the small battery drive device was not running.During in-house engineering evaluation it was found that the electronic control unit (ecu) was not functional and the electric motor had unusual vibration and was emitting a grinding noise.It was reported that there was no in a scheduled surgical procedure as an identical spare device was available for use.There was no patient involvement reported.There were no patient or user injuries reported.It was reported there was no medical intervention or prolonged hospitalization.The exact date of the event was not reported, however, it was noted that the event occurred in (b)(6) 2016.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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