The product was returned for investigation and the reported failure mode was confirmed.The failure mode will be monitored for future reoccurrence.Alleged failure: loose, does not fit well.According to biocomposites: investigation findings are: the use of the tarraja is considered an improper use of the medical device.Instructions for use must be understood and followed to allow the medical device to operate and function as desired/designed.The use of a tarraja weakened the screw, allowing it to break, leading to the loss of torque feeling.The suspected root causes are: improper use of the device, instructions for use not followed.The device manufacture date is not known.
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