STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, LEFT GAMMA3® Ø11X320MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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Model Number 3525-1320S |
Device Problems
Break (1069); Fracture (1260)
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Patient Problems
Failure of Implant (1924); Implant Pain (4561)
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Event Date 12/04/2021 |
Event Type
Injury
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Manufacturer Narrative
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Upon completion of investigation, additional information will be provided in a supplemental report.
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Event Description
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As reported: "broken gamma nail, 2 months post-surgery.Need a second medical procedure.Revision of gamma nail + u-blade column screw." update: when walking from toilet to the kitchen the patient suffered acute severe pain.She had to sit down and could no longer load the leg.
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Event Description
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As reported: "broken gamma nail, 2 months post-surgery.Need a second medical procedure.Revision of gamma nail + u-blade column screw." update: when walking from toilet to the kitchen the patient suffered acute severe pain.She had to sit down and could no longer load the leg.
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Manufacturer Narrative
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The reported event could be confirmed.Review of dhr, complaint history, capa databases and risk analysis did not identify any discrepancies.No nc/capa had been filed for the item in question.Potential nail breakage had been considered in the risk management file.Potential reasons for nail breakage are listed in the labelling.Physical investigation of the nail revealed it broke in a fatigue manner, originated by material damage at lateral in the posterior web of the proximal drill hole.Additionally, the nail was significantly loaded during the implantation period.Material and manufacturing deficiencies were not detected.Provided medical information was reviewed by a hcp who found surgical factors (suboptimal fracture reduction, suboptimal positioning of the lag screw) and patient related factors (fracture pattern, presumably poor bone metabolism because of the high age with reduced fracture healing potential, limited musculotendinous equipment due to the preexisting coxarthrosis) which may have contributed to the nail breakage.From technical point of view the event was caused by intraoperative material damage contributed by increased weight bearing.With available information a deficiency of the device was not verified.The cause of the event was determined being intraoperative material damage contributed by the patient.In case further substantive information becomes available we reserve the right to reopen the investigation with root cause assessment.
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