Aspen surgical received a report from the end user indicating that a needle broke during a procedure.An additional report was also received from the fda from the mail identifying this complaint and the issue from the end user.The actual device was not available for evaluation.The manufacturing lot number and photographic evidence was provided for review.The end user indicated that a 1/2 circle trocar point mayo catgut needle broke at the base of the eye section during a cervical cerclage procedure.The surgeon was unable to locate and retrieve the shaft section of the needle.The patient required follow ups with ultrasounds to monitor for the needle.Analysis result of the finished good lot number 65467 and incoming inspections of the raw material were reviewed.All samples passed acceptance criteria.No non-conformance's were noted in the dhr.Photographic evidence confirmed the broken needle condition.According to aspen surgical's ifu, the needles should not be clamped directly on the eye of the needle to the point and should be applied to the flat portion of the needle about 1/4 of the needle length from the eye end.Based on this information, due to no sample being returned, the root cause could not be determined and no further action is required.
|