STRYKER TRAUMA KIEL RECONSTRUCTION NAIL R1.5, TI, LEFT T2 RECON 9X360 MM X 125; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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Model Number 1843-0936S |
Device Problem
Fracture (1260)
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Patient Problems
Failure of Implant (1924); Injury (2348); Hip Fracture (2349); Limb Fracture (4518)
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Event Date 07/18/2020 |
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 in a supplemental report.Device discarded.
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Event Description
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As reported: "t2 reconstruction nail was used as a therapeutic material for subtrochanteric fractures of the femur on may 29.On july 16, when an outpatient visit was made to take a radiograph because of a fall, the presence of bone fragments was confirmed in the affected femur proximal part.Three days after returning home for follow-up observation, emergency transportation and x-ray confirmation were performed again.As a result, nail breakage and subtrochanteric fracture were confirmed near the nail lag screw insertion part.After removing the broken implant on 7/22, the t2alpha femoral nail was replaced again and fixed".Physician's point of view: it was the occurrence of bone fragments in a fall and stress concentration in the implant during early loading.
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Manufacturer Narrative
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The reported event could be confirmed with the help of x-ray provided.The device inspection was not possible as the product was not returned for investigation.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.The instructions for use instructs user that: ¿informing the patient: the surgeon must warn patient that the device cannot and does not replicate a normal healthy bone, that the device can break or become damaged as a result of strenuous activity, trauma, mal-union or non-union and that the device has a finite expected service life and may need to be removed at some time in the future.Explain the need to report unusual changes in the implantation area as well as falls or accidents even if the device or the site of operation did not appear to be harmed at the time.¿ more detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.However, one of the probable causes of the nail breakage could be fall of patient.Fatigue fracture (due to stress concentration in the implant during early loading) could also be one of the probable causes but that could be confirmed only if the device would have been returned and inspected.If device is returned or any further information is provided, the investigation report will be reassessed.
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Event Description
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As reported: "t2 reconstruction nail was used as a therapeutic material for subtrochanteric fractures of the femur on may 29.On july 16, when an outpatient visit was made to take a radiograph because of a fall, the presence of bone fragments was confirmed in the affected femur proximal part.Three days after returning home for follow-up observation, emergency transportation and x-ray confirmation were performed again.As a result, nail breakage and subtrochanteric fracture were confirmed near the nail lag screw insertion part.After removing the broken implant on 7/22, the t2alpha femoral nail was replaced again and fixed".Physician's point of view: it was the occurrence of bone fragments in a fall and stress concentration in the implant during early loading.
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Search Alerts/Recalls
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