STRYKER TRAUMA KIEL TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X180MM X 130°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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Catalog Number 31301180S |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problem
Bone Fracture(s) (1870)
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Event Date 06/25/2014 |
Event Type
Injury
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Manufacturer Narrative
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Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.Device disposition is unknown.
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Event Description
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Femur fracture with gamma 3 nail.Femoral head screw displaced into the pelvis, after an initially provided pertrochanteric femur fracture with a gamma3 nail.
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Manufacturer Narrative
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As no items were returned 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 nonconformance was not determined.No measures necessary for this case.The rmf considers that a revision surgery due to cut out or mobilization 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, patients' general condition, and primly the respective surgical technique.Based on the x-ray images provided it is confirmed that the set screw had not been reached the ground of the groove was unscrewed for more than ¼ of a turn resulting in exceeded motion of the lag screw towards medial; according to provided medical records the patient underwent the revision surgery with a sigma resection as a further consequence, which was performed 2.5 months after initial implantation.With available information a deficiency of the devices in question was not verified.
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Event Description
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Femur fracture with gamma 3 nail.Femoral head screw displaced into the pelvis, after an initially provided pertrochanteric femur fracture with a gamma3 nail.
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