DEPUY SYNTHES PRODUCTS LLC RECON SAGITTAL SAW WITH KEY FOR TRS; MOTOR, SURGICAL INSTRUMENT, AC-POWERED
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Catalog Number 05.001.240 |
Device Problem
Detachment Of Device Component (1104)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/16/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(6).The actual device was returned for evaluation.Reliability engineering evaluated the device and the reported condition was confirmed.A visual and functional assessment was performed on the device which found that the unit failed the saw blade coupling check and the set screw on the locking mechanism was found to be worn.It was further determined that the device failed the falling out protection steal ring check.During service/repair, it was observed that the magnetic support was broken, the set screw was worn and the threads came off the set screw and was stuck in the oscillator head.The assignable root cause was determined to be due to normal wear out from use.If information is obtained that was not available, a follow-up medwatch will be filed as appropriate.
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Event Description
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It was reported from (b)(6) that during pre-surgery for a hip procedure, it was discovered that the saw blade device would not hold in the recon sagittal saw device/power unit.It was further reported that another power unit device was able to hold the saw blade device.During in-house engineering evaluation, it was observed that the treads came off the set screw and was stuck in the oscillator head.There were no delays to the surgical procedure as a spare device was available for use.There was no patient involvement reported.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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