H3, h6: a 6.8mm guide bar was returned for inspection.It was reported that, during a thr was noticed the guide bar was bent.The procedure was completed without delay using a smith-nephew back-up device.No patient injury or other complications were reported.Due to worn laser marking, the batch number is not visible.Therefore a manufacturing record and complaint history review could not be performed.Visual inspection was performed which noted that there are marks and scratches across the device, consistent with surgical use.The guide bar has a slight bend.Laser marking is completely worn and no longer visible.Functional evaluation was performed which noted that assembly is acceptable.This confirms the reported complaint.It should be noted that the bhr surgical technique states, "examine instruments for wear or damage before use.While rare, intra-operative instrument breakage can occur.Instruments that have experienced excessive use or force may be susceptible to breakage".The probable root cause is unknown.If additional information becomes available in the future, this case will be reopened.No preventative or corrective action has been initiated as a result of this investigation.The instrument will be retained at aurora as it cannot be reworked or repaired.
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