DEPUY SYNTHES POWER TOOLS AIR OSCILLATOR; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
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Catalog Number 511.610 |
Device Problems
Device Inoperable (1663); Defective Device (2588); Protective Measures Problem (3015)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(4).(b)(6).This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.Reliability engineering evaluated the device and the reported condition was confirmed.The assignable root cause was determined to be due to improper maintenance, which is user error, misuse, and / or abuse.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 by (b)(6) that during service and evaluation, it was discovered that the coupling tool side was not functioning and was defective on the air oscillator device.It was further determined during the pre-repair diagnostics assessment that the device failed for check status of development, check saw blade quick coupling, check saw head, check for excessive noise, check frequency and for check performance.It was noted on the service order that the device did not "stand" the saw blade devices.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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