SYNTHES OBERDORF RADIOLUCENT-DRIVE; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
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Catalog Number 511.300 |
Device Problems
Device Stops Intermittently (1599); Noise, Audible (3273)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 04/03/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.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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Event Description
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It was reported from (b)(6) that during an external tibial nail for tibial diaphyseal fracture procedure, it was observed that the radiolucent drive device sounded different from usual then stopped drilling when the surgeon drilled a distal hole.According to the reporter, the device stopped because he pressed the drill bit device down to change the direction on the device.As a result, there was five minute delay in the surgical procedure.A spare device was not used as freehand locking technique was performed.There was patient involvement.There were no 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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Manufacturer Narrative
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This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.During repair, it was determined that the device had no function.The device was disassembled and it was observed that some teeth were broken off from the drive shaft and the bevel gear bush.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to improper handling which is user error/misuse/abuse.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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Search Alerts/Recalls
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