Investigation: inspection was done visually in microscope.Internal investigation: the wire of the brush is broken.As seen in pictures in the investigation file, the bristles of the device are heavily worn.The bristles are destroyed and lying down, the bristles have not been suitable to perform their function for some time.Both the twisted steel wires are broken, almost at the same place.No deformations or clamp marks that could have caused the breakage was found.This indicates that the breakage is not due to any failure in the wire material since the twisted wire is made of stainless steel and unlikely to be broken at same place.However, it is possible to break the wire if the brush head is bent back and forwards a couple of times.There are also signs of wear seen in the shaft of the brush, whitening in the material indicates that the rear end of the shaft has been bent.In the ifu for provox brush there is a warning picture showing that bending the brush head is not allowed.Conclusion: no material failure is found.The twisted metal wires of the brush have been broken off at same place and this can happened if the wire was bent several times.According to manual it not allowed to bend the brush on the metal wire.The breakage is most likely caused by wrong handling of the product.Corrective and preventive action: inform the patient to change the brush when it is worn and follow the ifu.Bending of the twisted wire is not allowed.If bending is necessary it has to be done on the blue shaft as described in the ifu.
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