DEPUY SYNTHES PRODUCTS LLC RECIPROC-SAW-ATTACHM F/EPD+APD; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
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Catalog Number 05.001.040.98 |
Device Problem
Bent (1059)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/14/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Manufacturing site name and address was unknown.The 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 information is obtained that was not available for the initial medwatch, 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 an orthognathic surgical procedure, it was observed that the tip of the reciprocating saw attachment device was noted to be broken prior to use.It was unknown if there were any delays to the surgical procedure.The procedure was completed using a milling cutter device.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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The manufacturer location was documented as unknown in the initial report.The location has been updated to (b)(4) contact office name/address has been updated accordingly to reflect the correct manufacturing facility.The device manufacture date was documented as unknown in the initial report.The device manufacture date has been updated as jan 15, 2007.If information is obtained that was not available, a follow-up medwatch will be filed as appropriate.
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Search Alerts/Recalls
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