[20613575]
According to the distributor, the tip of the knife broke off and was not recovered. Numerous images were taken to verify it was not left in pt. No pt injury was reported. Investigation: at the distributor's request, senior surgical instrument engineer, checked the instrument thoroughly and, in addition, reviewed the co's mfg records. The instrument in question was mfg with lot no. Mg 22 as one of 37 pcs. In may, 2004. Eight (8) pcs. Out of this lot were delivered to the distributor on 5/27/04. This is the first reportable incident that has come to the attention of the mfr. A thorough review of our production documents revealed no non-conformances, neither in materials or processes, nor from the customer's device sample and/or mfg specs. It passed the 100% quality and functional control prior to delivery. As part of this investigation, we performed a hardening test resulting in a value of 54. 4 hrc, well within the specified tolerance range from 50 - 58 hrc for this material. No material defects could be detected during visual inspection. Since the broken-off knife tip was not returned, the fracture point could not be examined. Conclusion: no definite conclusion for the exact cause of the fracture can be drawn. Based on our longterm experience as qualified surgical instrument mfr, we assume that the instrument may have become blunt, requiring the application of more force for the cutting action, thus causing the fracture of the delicate knife tip. Since a review of the production documents determined that all applicable specs have been met and since our trend analysis reflects no problem with this design, no capa action is required.
Patient Sequence No: 1, Text Type: N, H10