DEPUY SYNTHES POWER TOOLS SMALL BATTERY DRIVE INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
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Catalog Number 532.010VET |
Device Problem
Device Stops Intermittently (1599)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 03/08/2017 |
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 veterinary tibial plateau leveling osteotomy (tplo) surgery, it was observed that the small battery drive device had intermittent operation.
There was a sixty minute delay to the surgical procedure.
A spare device was available to complete the surgery.
There was no human patient involvement as the device was used in a veterinary procedure.
There were no reports of 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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The actual device was returned for evaluation.
Reliability engineering evaluated the device and the reported condition was not confirmed.
Therefore, an assignable root cause was not determined.
However, during evaluation, it was determined that the device did not work at all and was not functional.
It was further determined that the coupling head was worn.
It was observed that the electric motor was damaged, the device had rough rotation and the magnets came off the main gear.
It was further determined that the contacts were corroded on the electronic control unit and the gear parts and seals were worn.
It was determined that there was corrosion on the internal components.
It was further determined that these issues were consistent with component wear.
The assignable root cause was determined to be due to wear from normal use over time.
If information is obtained that was not available, a follow-up medwatch will be filed as appropriate.
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Search Alerts/Recalls
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