DEPUY SYNTHES PRODUCTS LLC SAGITTAL SAW ATTACHMENT, LONG, FOR TRS; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
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Catalog Number 05.001.224 |
Device Problem
Device Inoperable (1663)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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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 further determined that the bearings were rusted inside and did not run smoothly.It was further determined that the needle bearing was rusted and the needles were scattered inside of the housing of the attachment device.It was further determined that the surface of the needle bearing shell was rusted.It was observed that the adjuster fork was rusted on the surface and the coating was partly worn.It was observed that the shaft coupling had some light rust spots on the shaft where the bearing was located and the recess for the snapring.It was further determined that the eccentric shaft had pitting corrosion and a hair-line crack on the base of the shaft.It was further determined that the device failed pretest for check of free movement, check the oscillation frequency min 9900 to 12100osc/min and check the saw performance.It was further determined that all of the steps of the pre-repair diagnostic could not be performed because the attachment moved heavily.It was determined that the mechanics was dirty, oily and corroded.It was further determined that the mechanics seized, jammed and was moving heavy.It was observed that the bearing was not functioning and was defective.The assignable root cause was determined to be due to normal wear from normal use and servicing.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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Event Description
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This is report 10 of 10 for the same event: it was reported from (b)(6) that during an unspecified surgical procedure, it was discovered that seven sagittal saw attachment devices stopped working less than one minute after starting.It was not reported if there were any delays in the surgical procedure.There was patient involvement reported.It was not reported if there were any 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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