DEPUY SYNTHES PRODUCTS LLC OSCILLATING SAW ATTACHMENT II; BLADE, SAW, GENERAL AND PLASTIC SURGERY, SURGICAL
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Catalog Number 511.801 |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/27/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Reporter number (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 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 surgical procedure, it was observed that the oscillating saw attachment device had an unspecified malfunction.It was unknown if there were any delays to the surgical procedure.It was reported that a spare device was available for use.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 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 failed pretest for check the quick coupling for saw blades, and check oscillation frequency min 11,700 oscillation/minute.It was noted that the coupling tool side was not functioning.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to device use.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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Search Alerts/Recalls
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