Integra has completed their internal investigation on september 12, 2017.Results: dhr review; review of the lot record could not be conducted as the sterilization lot records could not be retrieved.Complaints history; a review of the complaint records for the same product description (futura or fgt) for the alleged hazardous situation/failure mode (product not sterile) showed two other complaint having been received, when all available records were searched (q4 2015 to present).The complaint rate was calculated based on the number of devices affected by the hazardous situation or failure mode (3), over the number of surgeries or units sold during the period of the review.Complaint rate: total # complaints = 3.Number of procedure = 2266 procedures as of (b)(6) 2017.Complaint rate = (b)(4).Conclusion: as the implant in question was not returned for investigation, a definitive root cause could not be found.However, possible root causes can be postulated based on the information supplied by the source of the complaint, and information gathered by integra subsequently.One allegation stated that the product expired in 2011.This appears to stem from a misreading of the symbol key label applied to the box.In investigating this claim, integra contacted the company who had labeled the product.The representative contacted stated, ¿in the picture of the single box, the symbol key is shown.The symbol key pictured ¿baw-0843¿ has an example date shown of ¿2011 06¿.This does not represent an original expiration date, only a dummy date code.¿ the true expiration date is shown on the end and top of each box.In viewing the generic symbol key label, the hospital staff apparently thought the 2011 date was the original sterilization date.The other allegation referred to the yellow ¿sticker,¿ which should have been green, leading them to think the product was not sterile.The ¿stickers,¿ or eto sterilization process indicators (as the manufacturer calls them), are, by turning green, designed only to indicate exposure to eto gas, and thus do not verify package sterility.Sterility is established through process validation and by the biological indicators placed in each sterilization run.
|