Corrections in h3 additional information in h6: component codes, type of investigations, findings, and conclusions.Device evaluation: visual inspection revealed that six of the seven returned devices have damaged threads, one of these also has drive mechanism damage.One of the seven has only drive mechanism damage.Potential cause: root cause was unable to be determined.This event could possibly be attributed to cross threading during use and off-axis forces applied during insertion.Dhr review: per dhr review, the part was likely conforming when it left zimmer biomet control.Device use : this device is used for treatment.A follow-up report will be submitted if new information is received that changes the information provided in this report.
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