Zimmer biomet complaint (b)(4).The device will not be returned for analysis as it was successfully implanted; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2020-00308, 0001032347-2020-00375, 0001032347-2020-00376.Medical products: lorenz pectus support bar system, part# pt-3652, lot# 989080.Lorenz pectus support bar system, part# pt-3653, lot# 989070.Lorenz pectus support bar system, part# pt-3654, lot# 989060.
|
This follow-up report is being submitted to relay additional information.The product was not returned for investigation as it was implanted.The complaint was confirmed by a review of intraoperative photos.The surgeon stated the ends were flared out too far and they had to be bent to make the bar sit flush.Per the ifu, "the degree of initial reshaping and permanent remodeling for each case cannot be predetermined." the manufacturing history was reviewed and no discrepancies related to the reported event were found.A complaint history review was conducted and this was the only complaint (3 parts total) of the bars not being contoured correctly.This leads to a complaint rate of 0.24%, which is no greater than the occurrence listed in the application fmea.Root cause was unable to be determined.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: date of this report.Describe event or problem.Date received by manufacturer.If follow-up, what type.Device evaluated by manufacturer.Not returned to manufacturer.Method.Results.Conclusions.Additional narratives/data.
|