It was reported that during an acl surgery, when the surgeon was drilling through the tibia the tip of the 2.4mm passing pin broke off.No significant delay was reported (<5 minutes).Smith and nephew back up device was used to complete the surgery and the broken pieces were removed by using tweezers.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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One passing pin 2.4mm used during treatment, was not retuned for evaluation.Without the reported product a visual and functional evaluation cannot be performed and the customer¿s complaint cannot be confirmed.The information provided states ¿during an acl surgery, when the surgeon was drilling through the tibia the tip of the 2.4mm broke off, it was also reported that when the femur was being drilled the tip broke off again¿.An exact root cause cannot be determined with confidence.
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