Product inquiry states the long nail kit r1.5, ti, right gamma3® ø10x260mm x 125° to be the primary product.No further associated products were reported.Review of the device history records, in particular the labelling copy sheet, revealed no discrepancies.A physical examination could not be carried out as the device was not returned to stryker (b)(4).As no further information such as x-ray images were provided due to hospital policy.The reported event could therefore not be confirmed.The event description states that ¿the physician accidentally deployed the right long gamma nail on the left¿.However, the labels on the packaging clearly indicate left and right nail by capital letters.The written description is available on the outer box as well as on the blister inside.In addition, left or right is engraved on the gamma3 long nail accordingly.Based on the above facts the root cause of the reported event is not linked to a deficiency of the device but is rather related to deviation from surgical technique by the user.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 open actions in place related to the reported event for the subject product.No non-conformity was identified.
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