N
Patient 1
PLEASE NOTE THAT EVEN THOUGH THE CONCLUSION CHOSEN WAS MANUFACTURING DEFICIENCY. THE PROBLEM WAS CAUSED FROM A RAW MATERIAL USED TO MAKE THE BRACE THAT IS PURCHASED FROM AN OUTSIDE VENDOR. INVESTIGATION FINDINGS: COMPLAINT SAMPLE WAS RECEIVED. THE WIRES THAT ARE PART OF THE BOA FASTENING SYSTEM WERE FRAYED (SEE FILE "FIGURE 1 BOA WIRE PIC"). SINCE THE LOT NUMBER GIVEN (30465618) THE MANUFACTURING DATE WAS TRACED. THIS WAS MANUFACTURED ON 01/14/2013. DURING THE TIME THIS PRODUCT WAS FOR THIS SAME ISSUE DESCRIBED. THAT THE WIRES ON THE BACK SUPPORT ARE FRAYING AND HAVE CUT THE PATIENT OR SNAGGED HIM A FEW TIMES. THE WIRES DESCRIBED IN THE COMPLAINT ARE PART OF THE (B)(4) CLOSURE SYSTEM. (B)(4) IS A CLOSURE SYSTEM USED IN MEDICAL AND SPORT DEVICES. IT IS OWNED BY (B)(4). THIS SYSTEM IS PURCHASED FROM (B)(4) AND USED AS A RAW MATERIAL FOR MANY OF OUR BRACING PRODUCTS. A SUPPLIER NOTIFICATION LETTER (SNL) WAS ISSUED TO (B)(4) TO REQUEST THEY INVESTIGATE THIS PROBLEM WITH THEIR WIRES. (B)(4) PERFORMED AN INVESTIGATION AND FOUND THAT THERE WAS A FLAW IN THE LACE (WIRE) OBTAINED FROM THEIR SUPPLIERS. AS A RESULT THE (B)(4) REPRESENTATIVE STATED TO DEROYAL QC INVESTIGATOR BY EMAIL THE FOLLOWING: THERE WAS A BAD BATCH OF WIRES THAT GOT OUT TO THE MARKET. DUE TO THE SMALL SIZE OF THE ISSUE, A FORMAL CORRECTIVE ACTION WAS NOT FILED. THEY HAD AN INFORMAL COMMUNICATION WITH THEIR WIRE VENDOR. CLOSE INSPECTIONS WERE IMPLEMENTED AND NO OTHER ISSUES HAD BEEN FOUND BY THEM. CORRECTION: REPLACEMENT PRODUCT WAS SENT TO CUSTOMER. ROOT CAUSE ANALYSIS: THIS IS VERY LIKELY TO THE VENDOR ISSUE THAT WE PREVIOUSLY HAD, AS THE MANUFACTURING DATE MATCHES THE TIME PERIOD WHEN THIS PROBLEM OCCURRED. CORRECTIVE ACTION AND/OR SYSTEMIC CORRECTION ACTION TAKEN: AS DISCUSSED ABOVE, THE VENDOR HAS ALREADY BEEN CONTACTED ABOUT THIS AND THEY PERFORMED AN INVESTIGATION TO SOLVE THE PROBLEM. THERE HAVE BEEN NO OTHER ISSUES ON WIRE FRAYING THIS YEAR. NO NEW ACTION IS REQUIRED AT THIS TIME. PREVENTIVE ACTION: THERE IS NO PREVENTATIVE ACTION NEEDED AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW UP REPORT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.