DEPUY SYNTHES PRODUCTS LLC SMALL BATTERY DRIVE II; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
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Catalog Number 532.110 |
Device Problem
Device Stops Intermittently (1599)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/11/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Device was used for treatment, not diagnosis.Additional narrative: the actual device was returned without an alleged deficiency.During routine service and repair of the device, it was observed that the device would not oscillate when power was applied.Also, the device was working intermittently.Therefore, the reported condition was confirmed.It was further observed that the electronic control unit (ecu) was damaged.It was noted that there was no voltage output.The assignable root cause was determined to be due to normal use over time.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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Event Description
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It was reported that during service and repair/pre-testing, it was observed that the small battery drive device would not oscillate when power was applied, and the device was also working intermittently.The event was not related to surgery.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 report will be submitted accordingly.
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Search Alerts/Recalls
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