DEPUY SYNTHES POWER TOOLS RECIPROCATING MICRO SAW; DRILLS, BURRS, TREPHINES & ACCESSORIES - MICRO SAW
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Catalog Number R-SAW |
Device Problem
Temperature Problem (3022)
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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).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If additional information should become available, a supplemental medwatch report will be sent accordingly.
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Event Description
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It was reported from (b)(6) that the attachment device became unusually warm.It was not reported if the device was used in surgery, or if there was patient involvement reported.It was not reported if there were any delays in a scheduled surgical procedure or if a spare device was available for use.It was not reported if there were any injuries, medical intervention or prolonged hospitalization.The exact date of this 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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Manufacturer Narrative
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The actual device was returned for evaluation.Reliability engineering evaluated the device and observed that the reported condition was not confirmed.It was further noted that during pre-test, less than three seconds into the test the device stopped running and the console displayed an e2 error.It was also noted that the device could not be disassembled (due to corrosion).The assignable root cause was determined to be due to immersion during cleaning and a failure to follow the directions for use which is user error.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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