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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