The product was returned for investigation and the reported failure mode was confirmed.The failure mode will be monitored for future reoccurrence.Alleged failure: screw broke.According to biocomposites: "investigation findings are: minimal information has been provided relating to the screw breakage complaint.Warnings and precautions, including prevention of screw breakage are stated in the instructions for use.No medical intervention was required.Surgery was completed successfully.No delay in surgery.If the tapped depth is not deep enough, the bottom of the screw stays stationary and the peak (top half) of the screw continues to twist causing breakage.The suspected root causes are user error in method used- if the tapped depth is not deep enough, the bottom of the screw stays stationary and the peak (top half) of the screw continues to twist causing breakage." manufacture date is not known.
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