DEPUY SYNTHES POWER TOOLS MINIMAL ACCESS ANGLE DRIVER, G1; DRILLS, BURRS, TREPHINES AND ACCESSORIES (SIMPLE, POWERED)
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Catalog Number MA-D20-G1 |
Device Problems
Mechanical Problem (1384); 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).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 an unspecified surgical procedure it was observed that the burr device was not sticking in the attachment device.It was reported that there was five minute delay in the procedure, and an unspecified spare device was available for use and the procedure was successfully completed.It was reported that the attachment device was successfully tested during pre-surgery set up.There was patient involvement reported.There were no reports of 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 has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.
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Manufacturer Narrative
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The actual device was returned for evaluation.Reliability engineering evaluated the device and the reported condition was not confirmed.An assessment was performed and the device met all manufacture's specifications.Therefore, an assignable root cause was not determined.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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