Manufacturing site evaluation: we received a complaint about one bc259b: noir baby-metz scissors cvd.The instrument arrived in a decontaminated condition and it is available for investigation.The broken off part is missing.During the intraoperative surgery the tip of the scissors broken.A x-ray for discard foreign body to the patient was necessary but the part wasn't found.Intra-operative medical intervention was necessary.Investigation: the investigation was carried out visually and microscopically with the digital microscope.We made a visual inspection of the instrument.Here we found visible damage and this is in an alignment with the fracture surface.Additionally we detected grooves.Furthermore we made an optical inspection of the fracture surface.Here we discovered discolorations and secondary damage but no anomalies were found.Batch history review: device quality and manufacturing history records have been checked for the lot number (4507294698) and found to be according to the specification, valid at the time of production.No similar incidents have been filed with products from this batch.Rationale: investigations lead to the assumption that the breakage was caused due to improper handling or the breakage was caused due to a stress-corrosion cracking.It appears that the dark discolorations are signs of an old crack.A pre-damage could have caused by a mechanical overload situation due to torsion or high leverage with the instrument.By an existing pre-damage or weak point, the reprocessing could be fracture-triggering.The secondary damages could have been caused due to movement of both parts each other after a crack.Due to the alignment of the fracture point and the visible damage, it appears that the breakage could have occurred during cutting.The grooves at the male box-lock could have caused due to an insufficient lubrication or foreign bodies.
|