The reported event could be confirmed based on the information provided and the subsequent return of the complaint device.Examination of the returned device finds it is cut into 3 pieces.Suture threads are still present in the ends.The instrument is red as intended for the 6mm sizer.Sizers are intended to facilitate implant size determination and should not be implanted since they do not meet implant design specifications.Sizers are provided non-sterile and are color coded based on size.Implants are provided sterile and are clear / translucent.Label masters for the last two revisions were reviewed and confirmed the following statement, "caution: not for implantation" and non-sterile symbol was also found to be present.Based on investigation, the root cause was attributed to a user related issue.The event was caused by hcp and staff failing to identify the color coded sizer was not to be implanted.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.If the device is returned or if any additional information is provided, the investigation will be reassessed.
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