STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø10X320MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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Catalog Number 34250320S |
Device Problem
Malposition of Device (2616)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/01/2018 |
Event Type
Injury
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Manufacturer Narrative
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Once the investigation has been completed any additional information will be reported in a supplemental report.
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Event Description
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On (b)(6) 2018 long gamma nail was implanted in femoris of the right femoral trochanter as primary procedure.About 3 weeks after surgery, the lag screw was backed out, and replaced it to the artificial femoral head at (b)(6) 2018.The bone quality and the skeletal position were not good.
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Event Description
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(b)(6) 2018 long gamma nail was implanted in femoris of the right femoral trochanter as primary procedure.About 3 weeks after surgery, the lag screw was backed out, and replaced it to the artificial femoral head at (b)(6) 2018.The bone quality and the skeletal position were not good.
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Manufacturer Narrative
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The reported event that long nail kit r1.5, ti, right gamma3® ø10x320mm x 125° was alleged of issue (implant revision / removal without implant breakage) could be confirmed.Visual inspection of the received lag screw shows traces of use.There are shiny marks on the periphery of returned lag screw - identified as material abrasion respectively significant bearing points during the period of implantation.The formation of these marks indicates rotation of the lag screw.Nevertheless, no mark or imprint is visible at the ground of the grooves.If the set screw would have been inserted as intended, a small imprint would be visible at the ground of one of the grooves.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.The operative technique gives clear instruction on the entire procedure including implant size selection in the preplanning stage, lag screw length measurement, lag screw insertion and lag screw fixation.Based on investigation, the root cause was attributed to a user related issue.The failure was caused by loosely inserted set screw.If the set screw would have been inserted as intended, a small imprint would be visible at the ground of one of the grooves.If any further information is provided, the complaint report will be updated.
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