DEPUY SYNTHES PRODUCTS LLC OSCILLATING SAW ATCH, LARGE, WITH KEY; BLADE, SAW, GENERAL AND PLASTIC SURGERY, SURGICAL
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Catalog Number 532.026 |
Device Problem
Material Disintegration (1177)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/26/2018 |
Event Type
malfunction
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Manufacturer Narrative
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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 that during post-surgery, it was discovered that the oscillating saw attachment device was broken into pieces.This event was not in relation to surgery.There was no patient involvement reported.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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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.The actual device was returned for evaluation.The device was evaluated, and the reported condition was confirmed.A visual and functional assessment was performed which found that the coupling tool side was missing parts.It was observed that a part had broken away from the tool coupling.It was further determined that the device failed pretest for check frequency.10800 to 13200 oscillation/minute and check the tool coupling.The assignable root cause was determined to be due to normal wear out from use.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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