The reported event could not be confirmed, since the returned device is conforming to specifications and fully functional.The device inspection revealed the following: the devices were returned in disassembled condition.The received device shows signs of usage evident by scratches on nail body and near the point of contact between the nail holding screw pegs and tibial nail.Overall, the device is in good condition.The received tibia nail was assembled.The nail was in loose condition but engaged in the corresponding pegs of the handle and could be disassembled easily.No indications of material, manufacturing or design related problems were found during the investigation.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.The instructions for use instructs user that: ¿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¿.Based on investigation, the root cause was attributed to a user related issue.The failure was caused by improper handling.If any further information is provided, the complaint report will be updated.
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