DEPUY SYNTHES POWER TOOLS UNIVERSAL BATTERY CHARGER II; BATTERY, REPLACEMENT, RECHARGEABLE
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Catalog Number 05.001.204 |
Device Problem
Defective Device (2588)
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Patient Problem
No Patient Involvement (2645)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(6).This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.Reliability engineering evaluated the device and observed that the loading bays one[1]+three[3]+ four[4] power tools were not loaded, the red led lights and the charger were defective.Therefore, the reported condition was confirmed.The assignable root cause was not determined to be due to wear from normal use and servicing.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 by (b)(6) that during service and evaluation, it was observed that the universal battery charger device red led was illuminated.It was further noted that the charger was defective, charging bay defects and loading bays one[1], three[3] and four[4] were not loaded.It was noted in the service order that the device charging bay three[3] was not working properly.This event did not occur during surgery.There was no patient involvement.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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Search Alerts/Recalls
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