It was reported that during acl procedure, the k wire device was acting as guide wire.The k wire snapped and fragment is embedded in femoral bone.Despite several attempts to get more information regarding the procedure and the patient condition, no response has been received from reporter.
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One 014859 sterile 1.5mmx12¿ guide wire reported on.Product was not returned for evaluation.The complaint stated: ¿it was reported that during acl procedure, the k wire device was acting as guide wire.The k wire snapped and fragment is embedded in femoral bone.Despite several attempts to get more information regarding the procedure and the patient condition, no response has been received from reporter.¿ due to unavailability, the allegation could not be fully confirmed.Definitive conclusions, investigation and evaluation were not possible without physical evaluation.If objective evidence becomes available to assist with evaluation, the complaint will be revisited.Factors that may affect device performance include: device storage, device ability, surgical ability, procedure location and tissue condition.Influences that could compromise product performance or integrity include: use of other that recommended smith & nephew drill.The primary cutting edges of the drill are not sharp or have dings and burrs.Stressed product from over torque or loss of axial alignment; the wires are intended to flex vs.Bend.Getting entangled up with other instruments or devices.Final product met predetermined specifications upon release to distribution.
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