DEPUY SYNTHES PRODUCTS LLC SAGITTAL SAW ATTACHMENT FOR TRS; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
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Model Number 05.001.223 |
Device Problem
Device Inoperable (1663)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 02/27/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(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 device coupling tool side did not function.The device also failed pretest for check the quick coupling for saw blades.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to premature wear.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 an unspecified surgical procedure, it was observed that the sagittal saw attachment device was not working.It was unknown if there were delays to the surgical procedure or if a spare device was available for use.There was patient involvement.There were no 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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