This follow-up report is being submitted to relay additional information.The complaint was opened because the facility reported the tip of the instrument broke during surgery and had to be surgically removed.The potts elevator #2 left (part# 09-0364, lot# 032615c15 ) was returned for investigation.Visual evaluation showed signs of use as there were minor scratches on the body of the elevator and the tip had fractured off.The complaint is confirmed.The most likely underlying cause of the complaint is that excessive force was used, beyond what the instrument was designed to encounter.The is the only complaint regarding the tip fracturing for the 09-0364 potts elevator #2 left lot 032615c15.For this part (09-0364) and the previous four years (from the notification date), there has been a complaint rate of (b)(4) which is no greater than the occurrence listed in the application fmea.The dhr was reviewed and there are no indications of a manufacturing defects.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.The following fields were updated: b4 updated to reflect date of report.B5 describe event or problem.D10 to reflect product return.G1-2 updated to reflect contact information.G4 date received by manufacturer.G7 updated to reflect type of report and follow-up number.H2 updated to reflect follow-up type.H3 updated to reflect device evaluated.H6 updated to reflect method, results & conclusions.H10 updated to reflect additional narratives/data provided.
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