During gamma3 surgery, the nail tip perforated anterior cortical bone.Since it was found after lag screw was completely implanted, the surgeon did not attempt re-insertion the nail.The surgery was finished after implantation of a locking screw.In the surgeon's opinion, the patient's cortical bone was very thin.
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The reported event that long nail kit r1.5, ti, right gamma3® ø10x340mm x 125° was alleged of 'adverse impact on patient / patient related / iatrogenic issue' could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.Based on investigation, the root cause was attributed to be user related.The failure was caused by implanting the device in a bone stock compromised by disease.Indeed, the reported event is an iatrogenic fracture, which is not the device's fault.As a reminder, the ifu states: " ensure that you are familiar with the intended uses, indications/contraindications, compatibility and correct handling of the implant, which are described in the operative technique manual for the product system.Please remember that product systems may be subject to alterations that affect the compatibility of the implant with other implants or with instruments.For your information, avail yourself of the training courses and publications offered (e.G.Operative techniques)," as well as: " bone stock compromised by disease, infection or prior implantation that can not provide adequate support and/ or fixation of the devices." a review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.
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During gamma3 surgery, the nail tip perforated anterior cortical bone.Since it was found after lag screw was completely implanted, the surgeon did not attempt re-insertion the nail.The surgery was finished after implantation of a locking screw.In the surgeon's opinion, the patient's cortical bone was very thin.
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