The evaluation revealed the broken nail to be the primary product.No deviations were found during review of the manufacturing and inspection documents (dhr).The nail was documented as faultless prior to distribution.The evaluation revealed that the nail broke most likely in a fatigue fracture after a period of approx.2 months of implantation.The kind of the bone fracture was not provided.According to found damages the fatigue fracture had its origination in the posterior web at lateral.In this area significant material damage had weekend the web caused by misaligned drilling with the step drill.Significant material deformation of the medial edge of the proximal drill hole was most likely caused by increased axial loading during the implantation period.Referring to found evidences the event was most likely caused by an unintentional use error.A medical review was not possible due to outstanding medical records.General aspects: the gamma3 nail is a temporary implant which inevitably will be subject of a fatigue fracture if the biomechanical stresses on the implant are too high or not considerably reduced during the period of implantation.During this period there is a race between bony consolidation / fracture healing and implant breakage as noted in the labelling of the product.Usually a breakage is contributed by one or more deficits, e.G.Insufficient bone healing, product damage.Generally the risk of a breakage will increase with the increase of load cycles and load level.Nail breakage in general has been experienced, but does not present an unanticipated event in itself.Depending on load application, also, depending on the patient¿s post implant behaviour and depending on suitable anatomical reduction, depending on the kind of bone breakage, depending on the course of bone healing and other factors ¿ e.G.Increased post-operative activities ¿ a nail breakage can rather be classified as anticipated; specifically if one or more contributing issues concurrence with each other.In this case it could not be determined whether the implant was suitable for treating the bone fracture, there was no information available if the implants had been placed in suitable manner and there was no information available if bone healing had developed in sufficient manner.Further, there was no information regarding potential patient diseases resp.Potential medication.As no post-operative weight bearing instructions were noted it could not be determined if the patient had been compliant resp.If the surgeon¿s instructions were appropriate.Nail breakage was most likely caused by intra-operative material damage of the proximal drill hole.It could not be excluded that increased loading bearing had contributed to the event.From technical point of view a more precise statement was not possible.In case further relevant information becomes available, we reserve the right to update the investigation and change the root cause.According to available information a deficiency of the nail was not be verified.
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