DEPUY SYNTHES POWER TOOLS LARGE OSCILLATING SAW ATTACHMENT F/532.0; BLADE, SAW, GENERAL AND PLASTIC SURGERY, SURGICAL
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Catalog Number 532.026 |
Device Problem
Difficult To Position (1467)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(4).(b)(6).The actual device was returned for evaluation.Reliability engineering evaluated the device and observed that the device passed all operational specifications.Therefore, the reported condition was not confirmed.An assignable root cause was not determined.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 unspecified veterinary surgical procedure, it was discovered that the cutter device did not stay locked on the oscillating saw attachment device that it caused major bleeding on two patients.It was unknown if there were any delays to the planned surgical procedure or if a spare device was available for use.There was no human patient involvement as this was a veterinary procedure.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of the event was unknown.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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