After further clinical review of this event with bard's medical department, this event was reassessed and determined to be mdr reportable as a malfunction pursuant to 21cfr part 803.A manufacturing review could not be performed, as the lot number is unknown.One finesse ultra 10g probe was returned for evaluation.Only a portion of the toothed rack was returned and the remaining pieces including the sample notch were not included with the returned sample.The break was located 55mm from the distal end of the vacuum rib.The returned broken toothed rack length was measured and found to be 136 mm.Therefore, approximately 73mm were broken off and not returned for evaluation.The investigation is confirmed for a broken toothed rack.As a result of the fractured toothed rack, functional testing could not be performed.The definitive root cause could not be determined based upon available information.It is unknown whether patient or procedural issues contributed to the event.The finesse biopsy probe instructions for use (ifu) provides general instructions for priming, firing, sampling and retrieval of samples from the device.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
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