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
Loose or Intermittent Connection (1371); Device Stops Intermittently (1599)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/23/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Additional narrative: (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 that during a hand pining extremity surgical procedure, it was observed that the small battery drive device was not working properly; would turn on and off, and had a bad connections and a loose gold prong.
According to the report, the device was in use one minute before the event occurred.
It was further reported that there was a five minute delay in the surgical procedure.
It was reported that a spare device was not used/needed.
There was patient involvement reported.
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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Additional narrative: the actual device was returned for evaluation.
Reliability engineering evaluated the device and the reported condition of the device not working properly, would turn on and off, and with bad connections and gold prong was loose was not confirmed.
Therefore, the assignable root cause was not determined.
However, during evaluation, it was noted that the bearings were corroded, the fillister head screw came loose and the motor was making an unusual noise.
It was determined that these failures were due to wear from normal wear (loctite degradation) and improper cleaning (cleaning and maintenance procedures not followed per directions for use).
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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