Added information to d3: email address, d8, h6: component codes, type of investigation, investigation findings, investigation conclusions.Corrected information in h3: this follow-up report is being submitted to relay additional information and initially corrected information.Summary: the complaint is confirmed for one (1) of one (1) returned polaris inserter (pn lv01114) for the failure of disassembly causing mating issues.Medical records were not provided for review.Device evaluation: visual inspection revealed the tip has fractured.Potential cause root cause was unable to be determined.This event could possibly be attributed to wear through use over time or multiple sterilization cycles.It could also be attributed to off-axis forces applied during insertion.Dhr review and related actions per dhr review, the part was likely conforming when it left zimmer biomet control.No actions required.This event is not related to any current actions or recalls or product holds.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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