STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø11X380MM X 130°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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Catalog Number 34301380S |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problem
Pain (1994)
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Event Date 07/11/2017 |
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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Gamma nail removed due to lag screw back out.Failure for set screw to capture.Pain.Implant backed out from bone.Removal and replacement was needed.
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Manufacturer Narrative
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As no items were returned resp.Made available for evaluation a physical evaluation was impossible.Review of the manufacturing documents revealed no discrepancies in material or in manufacturing.The review of the complaint history revealed the occurrence threshold being within estimated calculation.The review of the risk assessment indicated the issue was within tolerance, therefore no corrective actions are deemed necessary at this time.A non-conformance was not determined.No measures necessary for this case.Contraindications, warnings and precautions and potential adverse effects are pointed out in the ifu: the operation technique(s) are presented in the appropriate operation technique.The rmf considers that a revision surgery due to cut out or medialization is a typical complication of proximal femoral nailing.This harm does not primly depend on the implant.It is mostly caused by the kind of fracture, patient's general condition (osteoporosis), and primly the respective surgical technique.In the case of a cut out an extensive damage of the hip joint would result which has to be treated with arthroplasty.The basics of the gamma-system (shown in below sketch) are the interaction of nail set including a set screw and lag screw in the proximal area.The intention is to allow the fracture site to subside (if the fracture gap is too big) in order to support bone union.This requires motion in a relative rigid construction and is solved by lateralization of the lag screw.The set screw ¿ as part of the nail kit - is designed to fit into one of the four grooves of the shaft of the lag screw with ascending shapes at both medial and lateral.This prevents both rotation and complete migration of the lag screw but allows sliding in a limited and defined range.Due to missing medical information it could not be determined whether the event actually presented a medialization or rather a cut-out of the lag screw.In case of a cut-out the femur neck slips over the lag screw ¿ in most of the cases due to torsional displacement and/or poor bone substances.In case of medialization the lag screw proceeds into and sometime penetrates the femur head ¿ in most of the cases an insufficiently placed set screw has been the root cause.In both cases the event will not be caused by any deficiency of the device(s).The wording in the event description (lag screw back out) did not allow a final decision regarding the cause of the event.The file will be closed formally.In case relevant information resp.The part(s) become available we reserve the right to update the investigation and to change the root cause.With available information a deficiency of the devices in question was not verified.
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Event Description
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Gamma nail removed due to lag screw back out.Failure for set screw to capture.Pain.Implant backed out from bone.Removal and replacement was needed.
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Search Alerts/Recalls
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