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Patient 1
THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). THE RECEIVING / INSPECTION RECORD (RIR) FOR THE UNIVERSAL LEFT COCK-UP WRIST SPLINT, PART NUMBER 00176900300 AND LOT NUMBER 46165, REVIEW NOTED NO RELATED NON-CONFORMANCES, REQUESTS FOR DEVIATION (RFD), CHANGE NOTICES (CN), OR ANY OTHER ISSUES WITH MANUFACTURING. THE DHR REVIEW FOUND NO ISSUES WITH THE DEVICE AND ALL VERIFICATIONS, INSPECTIONS, AND TESTS WERE SUCCESSFULLY COMPLETED. ON 05 DEC 2016, IT WAS REPORTED FROM (B)(6) CARE THAT A UNIVERSAL LEFT COCK-UP WRIST SPLINT CAUSED THE PATIENT TO BREAK OUT IN DERMATITIS WHILE WEARING THE DEVICE. ON 02 FEB 2017, THE FOAM MATERIAL COMPOSITION WAS INVESTIGATED BY THE SUPPLIER BASED ON A REPRESENTATIVE SAMPLE OF THE DEVICE FROM THE REPORTED MANUFACTURING LOT. THE ACTUAL RETURNED COMPLAINT PRODUCT WAS NOT FORWARDED TO THE SUPPLIER FOR TESTING. THE ATTACHED SUPPLIER SURVEY AND THIRD PARTY LAB TESTING REVEAL THAT THE RAW MATERIALS USED ON THE INSIDE OF THE SPLINT WHICH TOUCHES THE SKIN DID NOT CONTAIN ANY CHEMICALS THAT WOULD CAUSE IRRITATION TO THE SKIN SUCH AS LATEX, FORMALDEHYDE, OR DEHP. THE MATERIAL WAS ALSO CONFIRMED TO BE REACH COMPLIANT. THE RESULTS OF THE RETURNED PRODUCT INVESTIGATION CAN, THEREFORE, NOT CONFIRM THE REPORTED EVENT. THE SUPPLIER WAS NOT ABLE TO IDENTIFY ANY ALLERGENS IN THE RAW MATERIALS OF THE RELATED LOT NOR IDENTIFY ANY OTHER ISSUES THAT WOULD CAUSE AN IRRITATION FOR THE USER. THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE SPECIFICALLY DETERMINED WITH THE PROVIDED INFORMATION. THE INVESTIGATION WAS BASED ON THE INFORMATION THAT WAS PROVIDED INITIALLY AND ANY INFORMATION THAT WAS OBTAINED THROUGHOUT THE FOLLOW-UP PROCESS.