It was reported that there was an issue with bb542 - carbon steel scalpel blades #12d.
According to the complaint description, it was reported that the blades broke inside patient's mouth and remained in the gum.
Additional information received, that three scalpel blades of the mentioned type of it happened that the tip of the blade broke off during a standard operation ("unfolding").
The broken off parts were about 0.
5mm to 1mm long.
There were no patient injuries, i.
E.
Up to now such injuries are not known.
However, it can not rule out the possibility that further splinters of the blades may be discovered in future x-rays.
The adverse event / malfunction is filed under aag reference (b)(4).
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Investigation results: visual investigation: vigilance investigator carried out the pictorial documentation visually and microscopically.
The scalpel blade's form is relatively thin in comparison with the shape of the drawing.
Therefore a breakage of the tip is possible.
In a further complaint during a test with unopened samples the deformation and breakage of the tip could be reproduced by tipping the tip with force to a hard surface.
Batch history review: the device quality and manufacturing history records have been checked for the available lot number and were found to be according to our specifications valid at the time of production.
Review of the complaint history revealed that one similar complaint has been filed against products from this batch number.
The review of the risk assessment revealed that the overall risk level (severity x probability of occurrence) according to din en iso 14971 is acceptable.
Conclusion and measures/preventive measures: based upon the investigation results, the root cause of the reported issue can be traced back to a manufacturing-related failure.
Specifically, the form of the scalpel blade's tip is not according to the specification.
This is caused by a manufacturing issue and has not been detected during final inspection, due to a slip through.
This issue has been investigated by the manufacturing plant and corrective actions has been planned and will implemented.
A product safety case will be requested.
Any action regarding capa will be addressed with this case.
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