DEPUY SYNTHES PRODUCTS LLC SAGITTAL SAW ATTACHMENT FOR TRS; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED
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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 01/16/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Reporter¿s phone number: (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 additional information should become available, a supplemental medwatch report will be sent 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 saw attachment device did not work anymore.It was not reported if there were any delays in the surgical procedure.It was reported that 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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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 device bearing was not functioning and defective.It was also determined that the device failed pre-test for oscillation frequency, check the free movement and general condition.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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