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Customer has reported that the gamma nail was broken some time later being implanted.Patient was revised with long pfna nail.When extracting the gamma 3 nail, the nail was broken in 2 fragments.Patient fell going to the bathroom and had the bone breakage, in the second event she does not remember what happened.
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Evaluation revealed the reported trochanteric nail kit, ti gamma3® ø11x180mm x 130° to be the primary product.The reported lag screw and locking screw were considered to be concomitant products as they did not contribute to the event reported.A review of the device history records and of the raw material certificate revealed no deviation in the manufacturing process.The trochanteric nail kit was documented as faultless prior to distribution.Thus, we excluded deviations in material and manufacturing.A physical examination could not be carried out as the devices were not returned for evaluation.Thus, a reasonable examination and investigation was not possible.In the case presented a patient had been treated with a trochanteric nail on (b)(6) 2015 due to an intertrochanteric fracture of her left hip.According to information received the patient initially suffered a sudden fall when getting out of the bath without remembering how it occurred.After an implantation period of 3 months the patient was admitted to the hospital from her nursing home residence due to having been found on the morning of (b)(6) 2016 at the nursing home confused, disoriented, drowsy and not remembering anything about what had happened during the previous hours.The patient manages her medication herself and is not supervised.This had led to an overdose of medication due to an error in the patient¿s polypharmacy in the past.The patient was transferred to another hospital to continue her examination.On the patient¿s arrival she did not remember anything about what had happened.The only thing she reported was left inguinal pain in her hip over approximately 10 days with no history of trauma and which has been progressively worsening to the point of preventing her from walking.A pelvic x-rays had been carried out, which showed the trochanteric nail to be broken.The patient was revised on (b)(6) 2016.The broken trochanteric nail was removed.Following a new closed reduction, osteosynthesis was performed with a competitor¿s pfna nail.The ifu states any mental or neuromuscular disorder which would create an unacceptable risk of fixation failure or complications in postoperative care to be a contraindication.Nail breakage in general has been experienced.It does not present an unanticipated event in itself.Depending on the load application, also, depending on the patient¿s post implant behaviour, on the suitable anatomical reduction, on the kind of bone breakage and depending on the course of bone healing and other factors a nail breakage can rather be classified as anticipated ¿ specifically if one or more contributing issues concurrence with each other.A successful treatment requires sufficient bone healing during the implantation period.According to information received the patient had been diagnosed with osteoporosis, vitamin d deficiency and secondary hyperparathyroidism indicating the bone stock of the patient to be likely compromised.A nail will be subject of a fatigue fracture if the stresses on the implant are too high or not considerably reduced during the period of implantation.The affected implant is designed to withstand the normal loads during the implantation period, i.E.The implant must neither be exposed to peak loads e.G.Stumbling or falling nor to continuous stresses.Another prerequisite for a successful supply is undisturbed, normal bone healing.In case that such a situation does not occur, exceeding of the fatigue strength is to be expected and thus quite predictable complication.Due to the missing product it could not be determined in what manner the nail had broken.As the nail was not available it could further not be determined whether the nail had been damaged intra-operatively.It could also not be determined, if the patient had been compliant to the surgeon¿s instructions regarding post-operative weight bearing.As no further x-ray documentation showing the initial fracture and the broken nail prior to the revision surgery were available, a medical review was not possible.It could not be determined whether the use of the nail had the correct indication nor could be determined if the implants had been placed according to the anatomical requirements.Review of complaint history, capa databases and risk analysis did not identify any conspicuity.The review of the risk assessment for the failure mode indicated the issue was addressed adequately.There are no actions in place related to the reported event for the subject product.No non-conformity was identified.The file will be closed formally.In case relevant information resp.The part becomes available we reserve the right to update the investigation and to change the root cause.Based on the limited information a deficiency of the nail in question was not verified.With the information given an exact root cause could not be determined.
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Customer has reported that the gamma nail was broken some time later being implanted.Patient was revised with long pfna nail.When extracting the gamma 3 nail, the nail was broken in 2 fragments.Patient fell going to the bathroom and had the bone breakage, in the second event she does not remember what happened.Updated: in the revision surgery ((b)(6) 2016) there was a large hematoma due to a probable lesion of a limb of the gluteal artery, and the patient needed transfusion (hematite concentrate) in (b)(6) 2016, two every day.The surgeon has confirmed that the implant was not sent to stryker to investigation.
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