DEPUY SYNTHES PRODUCTS LLC AIR REAMER/DRILL; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
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Catalog Number 511.605 |
Device Problem
Output below Specifications (3004)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 08/09/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Device was used for treatment, not diagnosis.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 the air reamer/drill device lacked power.It was not reported if the event occurred during a surgical procedure.It was reported that there was no delay to a procedure due to the event.It was not reported if there was a spare device available for use.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 will be submitted accordingly.
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Search Alerts/Recalls
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