The device was returned to stryker sustainability solutions for evaluation.Upon visual inspection of the received complaint device, evidence of clinical use was identified.The jaws were found to be detached from the actuating shaft.Further inspection reveals the actuating shaft was bent inward making contact with the blade.The scalpel was tested and failed the initial testing with two tighten assembly errors followed by a replace instrument error.The scalpel rod was found to be slightly stuck to the actuating shaft due to the actuating shaft being bent inward.Gouges and high crack were identified on the blade outside of the cutting area as a result of contact with the shaft assembly.No damage to the shaft pin was observed.A review of the dhr supports that the device met all inspection and test criteria prior to release from stryker.Therefore, the most likely root cause(s) are: too much force or torque applied to instrument, or grasping/pulling.Contact with any and all metal or plastic instruments or objects when the instrument is activated.Mishandling subsequent to distribution from stryker.Jaws/blade subassembly damage or separation.The instructions for use (ifu) state: use the torque wrench (already mounted to the shaft) to tighten the blade onto the hand piece.Turn the torque wrench clockwise while holding only the gray hand piece until it clicks twice.Indicating that sufficient torque has been applied to secure the blade.Do not attempt to bend, sharpen, or otherwise alter the shape of the blade.Doing so may cause blade failure and user or patient injury.Avoid contact with any and all other instruments while the instrument is activated.Contact with staples, clips or other instruments while the instrument is activated may result in cracked or broken blades.Note: do not use any other means than the torque wrench to attach or detach the instrument from the hand piece.Note: do not torque the instrument by hand without the torque wrench or damage may occur to the hand piece.The reported event will continue to be monitored through post market surveillance.
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