The device was returned to stryker sustainability solutions for evaluation.Visual inspection of the returned complaint device revealed signs of damage to the distal end of the outer shaft.The cutting edge was marred and dented.The inner tip was broken off mid tooth area, with some cutting teeth remaining with the inner shaft.Galling appeared on the outer shaft.No device information was reported as the customer did not report lot # information.Therefore, the device history record (dhr) was unable to be verified.The results of the visual inspection determined that the reported event was confirmed.Therefore, the most likely root cause is the user applied too much force while prepping the device, resulting in damage to the blade.The instructions for use (ifu) state: before beginning the procedure, verify compatibility of all instruments and accessories.Plug in and set up the generator according to the instructions in the manufacturer¿s manual.Select an arthroscopic shaver with size, blade, and function most appropriate for the procedure.Inspect the instrument for overall condition and physical integrity.Do not use the instrument if any damage is noted.Return the instrument and packaging to stryker sustainability solutions if it is not in acceptable condition for surgery.Careful handling of the instrument is necessary to avoid damage or breakage as a result of excessive force.Do not apply excessive pressure or ¿side-load¿ the blade during use.Side-loading does not improve the performance of the instrument, can dull the blade, and/or produce metal particulates.Do not allow the arthroscopic shaver to come into contact with staples, clips or any metal object to avoid damage to the blade and possible patient injury.The tip of the bur or cutter must be irrigated periodically (general recommendation: once a minute) to cool the blade and prevent excised tissues from accumulating.Do not run the instrument without appropriate suction for the duration of the process.The reported event will continue to be monitored through post-market surveillance.
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It was reported the tip of the arthroscopic shaver broke off while inside the patient during a knee arthroscopy.The broken piece was retrieved immediately.There was no patient injury, medical intervention, or extended procedure time reported.These are commonly used devices that are readily available.The patient's condition following the procedure was good.
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