DEPUY SYNTHES PRODUCTS LLC BATTERY OSCILLATOR II FOR BPL II; MOTOR, SURGICAL INSTRUMENT, AC-POWERED
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Catalog Number 530.710 |
Device Problems
Crack (1135); Mechanical Jam (2983)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/13/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Device was used for treatment, not diagnosis.(b)(6).This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.During repair, it was determined that the assignable root cause of the reported condition of the defective trigger was due wear from normal use and servicing over time.It was further determined that the assignable root cause of the crack on the oscillating head was due to be improper construction and design.This issue has been captured in a capa.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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Event Description
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It was reported from (b)(6) that during service and evaluation, it was determined that the coupling tool side of the battery oscillating device was out of specification.It was noted that the oscillators and slide sleeve were cracked.It was further determined that the device failed pretest for trigger test, check saw blade coupling, and general condition.This event did not occur during surgery.There was no patient involvement.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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