DEPUY SYNTHES POWER TOOLS MINIMAL ACCESS ATTACHMENT; DRILLS, BURRS, TREPHINES AND ACCESSORIES (SIMPLE, POWERED)
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Catalog Number MA-15C |
Device Problems
Bent (1059); Sticking (1597)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/18/2015 |
Event Type
malfunction
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Manufacturer Narrative
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Additional narrative: device lot/serial number is unknown; therefore, the device manufacture date is unknown.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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This is report 1 of 2 for the same event.It was reported that during a spine surgical procedure, it was discovered that the bearing sleeve attachment device used along with an unknown burr device was stuck inside angle driver attachment device.It was further reported that the bearing sleeve attachment was bent.According to the reporter, there was no fracture to the burr.There were no delays to the surgical procedure and spare devices were available for use.The surgery was successfully completed.There was patient involvement reported.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of the event was not reported.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 initial report stated that the event report was 1 of 2 for the same event.Upon complaint review, it has been determined that this is report 1 of 3 for the same event to reflect the correct number of report sequence.If information is obtained that was not available, a follow-up medwatch will be filed as appropriate.
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Event Description
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This is report 1 of 3 for the same event.
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Manufacturer Narrative
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The lot number was documented as unknown in the initial report.It has been updated to b463014489.Device manufacture date: the device manufacture date was documented as unknown in the initial report.The device manufacture date has been updated as mar 6, 2009.Device evaluation: the actual device was returned for evaluation.Reliability engineering evaluated the device and observed that the bearing sleeve was not bent and was fully functioning.Therefore, the reported condition was not confirmed.An assignable root cause was not determined.If additional information should become available, a supplemental medwatch report will be sent accordingly.
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