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 Problems
Overheating of Device (1437); Intermittent Energy Output (4025)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/20/2018 |
Event Type
malfunction
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Manufacturer Narrative
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The device serial or lot number was unknown; therefore, udi: (b)(4).The manufacturing location was unknown.Device manufacture date was unknown.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 the saw device overheated then stopped working.A new battery was installed but still did not work.It was not reported if the device was used in surgery, or if there was patient involvement.It was not reported if there were any delays in the surgical procedure, or if a spare device was available for use.It was not reported if there were any injuries, medical intervention or prolonged hospitalization.The exact date of this event is unknown.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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Search Alerts/Recalls
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