It was reported to aesculap ag that a bipolar cup handle f/trial heads cvd (part # nf771r) was used during a procedure performed on (b)(6) 2022.According to the complainant, the tip of the trial handle broke during surgery.During surgery, the tip of the nf770r deviated from the handle body.Since this event occurred when the nf770r was installed in the bipolar cup trial, the tip remained inside the cup.The remained bipolar cup was close to the planned size, so the doctor removed the tip part and tried to use it, but could not remove it.The procedure was able to be successfully completed using another size device.The complaint device has not been returned to the manufacturer for evaluation.An additional medical intervention was necessary.Although requested, additional information has not been made available.The adverse event is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2022-00060 ((b)(4) nf771r).9610612-2022-00004 ((b)(4) nf770r).Involved components: ng094 - bipolar cup trial head (b)(4)- lot unknown.
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Updated h6: codes.Investigation results: visual investigation: the investigation was carried out visually and microscopically.The working end of nf770r has detached from the shaft.Here we found a loosened solder joint at the working end of nf770r.The other products show no visible damages.Batch history review: due to the fact that no lot number was provided, a review of the device history records for the complained device is not possible.The review of risk assessment revealed that the overall risk level (severity 1(5) x probability of occurrence 2(5)) according to din en iso 14971 is still acceptable.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.Based upon the investigations results a capa is not necessary.
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