It was reported that while in use, one of the device's grasping ends broke off into the patient.It was also reported that the piece was retrieved without intervention, the device was replaced, and that the procedure was completed successfully.There was no patient injury, medical intervention, or extended procedure time reported.These are commonly used devices that are readily available.
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The device was returned to stryker sustainability solutions for evaluation.Upon inspection of the received complaint device, the blade was fractured and the fractured portion of the blade was not returned.The results of the visual inspection determined that the reported event was confirmed for fractured blade.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.Incidental and prolonged activation against solid surfaces, such as bone or plastic.Attempting to bend, sharpen, or otherwise alter the shape of the blade.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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