DEPUY SYNTHES PRODUCTS LLC COMPACT AIR DRIVE II; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
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Catalog Number 511.701 |
Device Problems
Device Operates Differently Than Expected (2913); Output below Specifications (3004)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/01/2018 |
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 from (b)(6) that during a demonstration test, it was discovered that the power of the compact air drive device was low and the device stopped in-between.There was no patient involvement reported.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of the event was unknown.However, it was reported that the event occurred in 2018.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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This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.During repair, it was determined that the reported condition was confirmed.It was determined that the motor power was too low.It was further determined that the device failed pretest for check the power with test bench: min.110 to 160 watts.The assignable root cause was determined to be due to premature wear from normal use servicing.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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