DEPUY SYNTHES POWER TOOLS OSCILL-SAW-ATTACHM F/532.001 532.010 532; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
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Catalog Number 532.021 |
Device Problem
Detachment Of Device Component (1104)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/03/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).(b)(6).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 from turkey that during a distal humerus fracture surgical procedure, it was discovered that the oscillating saw attachment device separated.It was reported that the event occurred during use on a patient.There were no delays to the surgical procedure as a spare device was available for use.There was patient involvement reported.It was not reported if there were any 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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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 reported condition was confirmed.It was observed that the coupling sleeve was detached from the bearing housing, the device was partly dismantled and two of the gear wheels were missing.It was further determined that the device failed pretest for check the machine coupling, check the function of the positioning ring and verify if secured with pin, there was no pin.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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