Primary procedure, right femur.It was reported that a ring came off of the targeter where it attaches to the nail while inside the patient.The surgeon was able to retrieve the ring with a reported surgical delay of less than 2 minutes.Rep was not present for the procedure.The rep has provided a picture of the targeter and the ring.The targeter is available for return (the nail was implanted), but the ring was lost by the hospital.No adverse consequences to patient due to surgical delay.
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The reported event that target device, g3 plus gamma3® was alleged of 'instruments - broken, deformed, worn or scratched' could be confirmed.Based on investigation, the root cause was attributed to be user related.The c-ring was found deformed and was attached in a wrong position.This may have been caused by detachement for cleaning purposes by re-attachement in improper manner.The failure was caused by misuse.The device inspection revealed the following: the picture sent by the hospital shows indeed that the c-ring was disconnected from the targeter.The ring in question is highly deformed.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 any further information is provided, the investigation report will be updated.
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Primary procedure, right femur.It was reported that a ring came off of the targeter where it attaches to the nail while inside the patient.The surgeon was able to retrieve the ring with a reported surgical delay of less than 2 minutes.Rep was not present for the procedure.The rep has provided a picture of the targeter and the ring.The targeter is available for return (the nail was implanted), but the ring was lost by the hospital.No adverse consequences to patient due to surgical delay.
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