N
Patient 1
INTRODUCTION DURING THE TIME PERIOD OF JANUARY 1, 2015 TO JANUARY 29, 2016, DEROYAL HAS RECEIVE A TOTAL OF 6 COMPLAINTS REPORTING THE MALFUNCTION OF THE EMT SELECT EXTRICATION COLLAR AT THE BLUE MOLDED PIECE. THE REFERENCE FOR THESE ARE (B)(4). THESE WERE RECENTLY ALL REVIEWED AGAIN. AS A RESULT, DEROYAL HAS MADE THE DECISION TO FILE TWO ADDITIONAL MDRS DUE TO BREAKAGE OF THIS PIECE UPON APPLICATION OF COLLAR ON A PATIENT (FOR (B)(4)). BOTH OF THE MDRS ARE FOR EVENTS THAT DEROYAL BECAME AWARE OF 6 TO 5 MONTHS AGO. THE REASON FOR THESE MDRS BEING FILED AFTER THE 30 DAY DEADLINE PER 21 CFR 803.50, IS THAT AT THE TIME THESE COMPLAINTS WERE RECEIVED, DEROYAL DID NOT CONSIDER THEM TO QUALIFY AS MDR REPORTABLE EVENTS PER 21 CFR 803.1 AND 803.3. ONCE WE REVIEWED THE REPORTED EVENTS AGAIN AND TOOK INTO ACCOUNT WHAT WE HAVE LEARNED OVER THE COURSE OF OUR INVESTIGATION, IT WAS DECIDED TO FILE REPORTS FOR THESE. MDRS WERE ALREADY FILED FOR COMPLAINTS (B)(4). FOLLOW UP REPORTS WILL BE SUBMITTED FOR THESE TO UPDATE WITH MOST RECENT FINDINGS. THIS MDR IS FOR COMPLAINT NUMBER (B)(4). THE FULL LIST OF MDR FILED AND CORRESPONDING COMPLAINT NUMBER ARE AS FOLLOW: COMPLAINT (B)(4) - MDR 3006851902-2016-00005, COMPLAINT (B)(4) - MDR 3006851902-2016-00006, COMPLAINT (B)(4) - MDR 3006851902-2015-00001 (CORRESPONDING MEDWATCH (B)(4)), COMPLAINT (B)(4) - MDR 3006851902-2015-00002 (CORRESPONDING MEDWATCH (B)(4)), COMPLAINT (B)(4) - MDR 3006851902-2015-00003 (CORRESPONDING MEDWATCH (B)(4)). BACKGROUND THE PRODUCT 1044-31, CERVICAL COLLAR EMT SELECT, IS ALSO SOLD UNDER SIX OTHER PART NUMBERS: A111-000, 1044-30, 1044-90, 14-103A-00, 1117PP, AND 300N10. THIS PRODUCT USED TO BE PURCHASED FROM AN OUTSIDE VENDOR. IN 2013, DEROYAL STARTED MANUFACTURING THIS PRODUCT IN-HOUSE. THERE WAS A PREVIOUS INVESTIGATION INTO COMPLAINTS THAT REPORTED BREAKS AT THE WHITE POLYPROPYLENE CHIN PIECE. THE FAILURE MODE AND CORRECTIVE ACTION FOR THOSE OCCURRENCES ARE COMPLETELY DIFFERENT THAN THE MALFUNCTION DESCRIBED HERE (B)(4). INVESTIGATION FINDINGS IN OCTOBER OF 2015, DEROYAL NOTICED FOUR COMPLAINTS (B)(4) THAT REPORTED THE EMT SELECT EXTRACTION COLLARS BREAKING AT THE BLUE PLASTIC PIECE (FIGURE 1 IN ATTACHMENTS). THIS PIECE IS MOLDED AND MADE FROM HIGH DENSITY POLYETHYLENE (HDPE) RESIN. IT IS CALLED THE ADULT FRONT BODY, PART NUMBER HDP0302B. AS A RESULT, A CAPA INVESTIGATION WAS IMMEDIATELY INITIATED (B)(4). THE MANUFACTURING PROCESS WAS REVIEWED TO VERIFY COMPLIANCE WITH DEROYAL PROCEDURES. NO INCONSISTENCIES WERE FOUND. MEMBERS OF THE INVESTIGATION TEAM ATTEMPTED TO REPRODUCE THE REPORTED BREAKS. WHEN HANDLED AS DIRECTED, INVESTIGATORS WERE UNABLE TO INDUCE A BREAK AT THE BLUE PLASTIC PIECE. OF COURSE A BREAK CAN BE INDUCED IF COLLAR IS HANDLED ROUGHLY ENOUGH. INVESTIGATORS NOTICE THAT WHEN COLLAR IS BENT HARD ENOUGH, THE WAY THIS PART BREAKS IS THE SAME FOR ALL COLLARS TESTED AND COMPLAINT SAMPLES. IT STARTS AT THE V INTERSECTIONS WHERE 2 RIBS COME TOGETHER IN THE AREA AT THE NECK OF THE BLUE FRONT PIECE (SEE FIGURE 2 IN ATTACHMENTS). IT WAS THEORIZED THAT REINFORCING THIS AREA FOR THE COLLAR MAY RESULT IN INCREASED ROBUSTNESS TO ACCOUNT FOR WHEN THE COLLAR IS NOT HANDLED AS INTENDED. THE AREA WHERE THE BREAKS OCCUR WAS STRENGTHENED BY ADDING A RADIUS TO THE RIB JUNCTIONS. REINFORCING THIS AREA FOR THE COLLAR DID RESULT IN INCREASED ROBUSTNESS AS WAS SHOWN BY OUR TESTING (ATTACHMENT 1 AND 2 - ENG PCL 039 PROTOCOL AND SUMMARY REPORT). FIGURE 3 IN THE ATTACHMENTS SHOWS A PICTURE OF THIS PART WITH A DESCRIPTION OF THE CHANGES MADE TO THE CORRESPONDING MOLDING TOOL. THESE CHANGES WERE MADE ON DECEMBER 14, 2016. THE FIRST LOT OF OUR EMT SELECT EXTRICATION COLLARS THAT INCORPORATE THIS CHANGE HAS JUST BEEN MANUFACTURED (LOT 41545015 ON 01/27/2016). AS THE NEW LOTS OF OUR MODIFIED EMT SELECT EXTRICATION COLLARS GO OUT INTO THE MARKET, DEROYAL WILL CONTINUE TO MONITOR TRENDS FOR THESE FAILURE TYPES AND WILL RECOGNIZE IF IT BECOMES A RECURRING ISSUE. HEALTH RISK ASSESSMENT AS PART OF OUR INVESTIGATION, A HEALTH RISK ASSESSMENT (HRA) WAS PERFORMED, IN NOVEMBER 2015, TO SEE IF A PRODUCT RECALL WAS NECESSARY (ATTACHMENT 3). THE TEAM THAT TOOK PART IN THE ANALYSIS HAD REPRESENTATIVES FROM THE FOLLOWING DEPARTMENTS: REGULATORY, QUALITY ASSURANCE, ENGINEERING R & D, MARKETING AND MANUFACTURING (ENGINEERING, MOLDING AND TOOLING). (1) INVESTIGATORS CONCLUDED THAT USER ERROR IS THE LIKELY ROOT CAUSE. THE USER NOT HANDLING THE COLLAR AS INTENDED. WHEN APPLIED AS DIRECTED, INVESTIGATORS WERE UNABLE TO INDUCE MALFUNCTION. HOWEVER, MALFUNCTION COULD EVENTUALLY BE INDUCED IF THE COLLAR WAS BENT OR ROLLED TIGHTLY ENOUGH. THIS TYPE OF HANDLING IS NOT CONSISTENT WITH THE INSTRUCTIONS. (2) IN THE ANALYSIS, IT WAS DETERMINED THAT IF A DEVICE WERE TO MALFUNCTION, IT IS UNLIKELY TO RESULT IN INJURY. IF AN INJURY WERE TO OCCUR IT WOULD MOST LIKELY BE EITHER (A) TEMPORARY OR REVERSIBLE (WITHOUT MEDICAL INTERVENTION) OR (B) LIMITED (TRANSIENT, MINOR IMPAIRMENT OR COMPLAINTS). CON...