This follow-up report is being submitted to relay additional information.This complaint was confirmed by review of returned device.Visual evaluation of the returned product exhibits signs of repeated use, it is nicked and gouged especially the bottom surface features.Device history record (dhr) was reviewed and no discrepancies were found.A definitive root cause cannot be determined.The likely condition of the part when it left zimmer biomet control is considered conforming based on the evaluation of the returned product, the dhr review, and the potential field age of the device (18 months).The instruction for use manual instructs to visually inspect devices after each use and cleaning, and to request a replacement if damage or wear is noted that may compromise the function of an instrument.Also the user should check if instruments that form part of a larger assembly assemble readily with mating components.If polymer devices show excessive distortion or are visibly warped, they should be replaced.The root cause of the reported issue is attributed to expected wear and tear from repeated use over time.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
|