It was reported that during a knee arthroscopy, the fast fix 360 nail broke.The procedure was completed without significant delay using a back-up device.No patient injury or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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H10: h6: the reported fast-fix 360 kpsc and slotted cannula, used in treatment, has not been returned for evaluation.Without the reported product a visual and functional evaluation cannot be performed and the customers complaint cannot be confirmed.From the information provided, the device broke.An exact root cause cannot be determined with confidence, however, factors that could have contributed to the reported event include: excessive force placed on the device during use.The instruction for use outlines precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.A review of the manufacturing and complaint records was performed, there were no indications that would suggest that the device did not meet product specifications upon release into distribution.
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