(b)(4).Report source, foreign - event occurred in (b)(6).Reported event was confirmed as the pictures provided show the product broken.The product evaluation showed that the avantage curved handle shaft broke at the weld between the straight part and the curved part.It is possible that the two parts were not sufficient welded or that the weld was damaged by the polishing.Therefore, the product evaluation confirmed the reported event and the most probable cause of the event is a manufacturing issue.Dhr review : the review of the device manufacturing quality record indicates that 10 products avantage curved handle shaft, reference 110031338, batch 056790 were manufactured on 01 february 2018.The device manufacturing quality record indicates that the released product met all requirements to perform as intended.No non conformity or deviation was observed which could be linked to the event described in the complaint.Only this complaint has been recorded for avantage curved handle shaft, batch 056790 within one year.According to available data, the most probable root cause could be a manufacturing issue.A summary of the investigation was sent to the complainant conveying zimmer biomet conclusions; if any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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