(b)(4).Complaint sample was evaluated and the reported event was confirmed.Visual evaluation of the box found damages to the end flaps and side walls.The end flaps are torn and scuffed up.The side walls have creases.Inspection of the inner cavity shows that one corner has been folded over leaving a crease mark.There is also damage to the cavity lid label, it has a partial tear.Review of the device history records identified no related deviations or anomalies.The product was likely conforming when it left zimmer biomet control.Based on the damage observed on the product, it appears that the packaging has been damaged during transit; root cause can be attributed to transit damage.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.
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