DEPUY SYNTHES PRODUCTS LLC ELECTRIC PEN DRIVE 60,000 RPM; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESSORIES AND ATTACHMENT
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Catalog Number 05.001.010 |
Device Problem
Device Inoperable (1663)
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Patient Problems
No Consequences Or Impact To Patient (2199); Not Applicable (3189)
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Event Date 02/14/2018 |
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 a veterinary hemilaminectomy surgical procedure, it was observed that the electric pen drive device became unresponsive.As a result, there was a five minute delay in the surgical procedure.A competitor's spare device was available for use to complete the surgery.There was no human patient involvement as this was a veterinary procedure.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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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.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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This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.During repair, it was determined that the device had no power.The device also failed pretest for safety assessment (step #80; check function with test hand switch) because the device did not run and there was no function or motion.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to improper cleaning, which is user error/misuse/abuse.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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Search Alerts/Recalls
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