The device was not returned for analysis, which precluded a full investigation and analysis of the root cause.However, based on our knowledge of the device design and its prescribe use, the most likely scenario is that the user removed the marker applicator separately from the biopsy probe.Tip shear has been identified as a potential risk whenever the applicator shaft is removed separately through the biopsy probe once it has been positioned in the probe aperture for marker deployment.Our mammotome vacuum assisted biopsy probes contain extremely sharp edges along the aperture opening to effectively excise tissue.Removing the applicator shaft once it is exposed to the probe aperture creates the possibility of the applicator catching on one of these edges and shearing.As a mitigation step to address this risk, we provide warnings and precaution language and instruction within the instructions for use: warning: failure to align the mammomark applicator as specified may result in improper deployment of the collagen plug and possible tip shear.Warning #10: remove the mammomark applicator and the mammotme biopsy probe together as a single unit from the site and obtain images to confirm marker placement.Customer follow-up confirmed that the physician had removed the sheared tip from the breast with a hemostat.Due to the subsequent procedure to remove the tip we are submitting this medwatch report.Device discarded by customer.
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