BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X180MM X 130°

    MDR report key: 4134074 · Received October 2, 2014

    Report

    Report Number
    0009610622-2014-00530
    Event Type
    Injury
    Date Received
    October 2, 2014
    Date of Event
    November 13, 2010
    Report Date
    September 10, 2014
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    HSB
    PMA / PMN Number
    K034002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE ALLEGED EVENT (WOUND INFECTION) WAS REVIEWED IN LINE WITH THE "CHECKLIST INVESTIGATOR" ACCORDING TO LOCAL PROCEDURE DQF 13-002. REVIEW OF THE WHOLE DHR FOR THE NAIL CONCERNING RESULTS WHICH DO NOT MEET SPECIFICATIONS OR OTHER DEVIATION REPORTS INCLUDING ANY OBSERVATIONS AND REPORTS IN THE LOGBOOKS OF PRODUCTION EQUIPMENT: NO DISCREPANCIES FOUND. REVIEW OF THE STERILIZATION VALIDATIONS. CONFIRM THAT ALL ASSUMPTIONS ARE CORRECT AND THE CONCERNED PRODUCT WAS PRODUCED UNDER VALIDATED CONDITIONS: THE STERILIZATION PROCESS WAS VALIDATED BASED ON DIN EN ISO 11137/ 13485. A REGULAR AUDIT, PERFORMED ON DECEMBER 10, 2013, HAD CONFIRMED THE ABOVE MATTER. REVIEW OF THE INSTRUCTIONS FOR USE (IFU). CHECK THE STERILIZATION REQUESTS OF THE IFU. DO THEY COMPARE TO THE VALIDATED STERILIZATION PROCESS (SEE EXCERPT OF IFU IN DOCUMENT PAPER FILE): THE IFU INCLUDE ALTERNATIVE STERILIZATION METHODS, VALIDATED FROM STRYKER BASED ON REQUIREMENTS (I.E. DIN EN ISO 17665-1). A REVIEW OF THE IFU L 2200007 REGARDING VALIDATED STERILIZATION PROCESS SHOWED NO NON-CONFORMITIES. BOTH IFU AND CLEANING AND STERILIZATION BROCHURE (L24002000) REFER TO STEAM / MOIST-HEAT STERILIZATION (AT THE USER). CHECK CONFIRMATION TESTS FOR STERILITY (E.G. PACKAGING SEALS, TURBIDITY ON LIQUIDS, RED EXPOSURE STICKER), IF APPLICABLE: THE NAIL HAD SUCCESSFULLY UNDERGONE A PEEL TEST. A RADIATION DOT INFORMED THAT THE PRODUCT WAS STERILE. RADIATION DOT WAS PUT ON PACKAGE, CONFIRMED BY LABEL CONTROL IN DHR. STERILIZATION CERTIFICATE FROM VENDOR ((B)(4)/NAIL) CONFIRMED STERILIZATION. REVIEW OF RECORDS FOR THE ENVIRONMENTAL MONITORING OF PACKAGING FOR THE DAY OF PRODUCTION OF THE APPLICABLE LOT AND ENVIRONMENTAL DATA: THE PRODUCT WAS PACKED IN HOUSE WITHOUT CLEAN ROOM REQUIREMENTS. LOCAL REQUIREMENTS IN LINE WITH ISO 14644-1 ARE AA-264 AND AA-366. NO DEVIATION WAS FOUND DURING REVIEW OF PERIODIC TESTS OF POLLUTION OF THE ENVIRONMENT (AIR). REVIEW OF RECORDS FOR THE ENVIRONMENT MONITORING OF CLEAN ROOM FOR THE DAY OF PRODUCTION OF THE RELATED LOT AND ENVIRONMENTAL DATA: THE PRODUCT WAS PACKED IN HOUSE WITHOUT CLEAN ROOM REQUIREMENTS. LOCAL REQUIREMENTS IN LINE WITH ISO 14644-1 ARE LOCAL AA-264 AND AA-366. NO DEVIATION WAS FOUND DURING REVIEW OF PERIODIC TESTS OF POLLUTION OF THE ENVIRONMENT (AIR). IF APPLICABLE: CHECK THE RECORDS OF BIO BURDEN IDENTIFICATION ON THE DEVICE (TYPE) DURING ROUTINE MONITORING OR DOSE AUDITS OR ANNUAL REVALIDATIONS: THE FINAL REPORTS FOR DOSE-AUDITS (EXTERNAL LAB WAS COMMISSIONED BY THE MANUFACTURER), VAL_P0016_043, DATED 20.10.2009, AND VAL_P0016_052, DATED 06.10.2010, (NAILS) HAD BEEN EXAMINED IN SEPTEMBER / OCTOBER2009 RESP. JULY /SEPTEMBER 2010 BY THE INSTITUTE (B)(4). NO OBSERVATIONS WERE MADE. THE PRODUCTS WERE PROCESSED UNDER VALIDATED CONDITIONS. - CHECK STERILIZATION RECORDS FOR THE LOT FOR COMPLIANCE AND ALSO AGAINST VALIDATED PROCESS: THE STERILIZATION RECORD CERT-NO. (B)(4) (BGS) REVEALED THE DOSE BEING WITHIN SPECS FOR THE AFFECTED PRODUCT. NO OBSERVATIONS REGARDING SEALING TIMES, PRESSURES AND PEEL- / BURST TESTS. CHECK IF ANY DEVIATION OCCURRED DURING THE STERILIZATION CYCLE (I.E. LOW HUMIDITY, CONCENTRATION OF ETO) RECEIVED DOCUMENTS DID NOT SHOW ANY POTENTIAL DEVIATIONS - REF TO BGS CERTIFICATE. EXAMINATION OF THE FLORA THAT IS TYPICALLY FOUND IN THE CLEAN ROOM AREA BASED ON ROUTINELY CLEAN ROOM INVESTIGATIONS IN COMPARISON WITH THE INFORMATION FROM THE HOSPITAL CONCERNING THE INFECTION ORGANISM: THE PRODUCTS WERE PACKED IN-HOUSE WITHOUT CLEAN ROOM REQUIREMENTS - HOSPITAL FLORA WAS NOT AVAILABLE. A COMPARISON WAS NOT POSSIBLE. REVIEW OF ALL RELATED FMEAS: THE RISK ANALYSIS GAMMA3 SYSTEM RISK MANAGEMENT FILE / (B)(4), REV3 AND SPECIFIC CALCULATION FOR ESTIMATION OF ACCEPTANCE LEVEL FOR ALERT AND ACTION LIMITS (ACC. DQF 30-505 - REPORT-NO 14-215 / INFECTION) WAS REVIEWED; NO DISCREPANCIES WERE FOUND. IF SOME OF THE RELATED PROCEDURES ARE DONE BY SUPPLIERS OR COSTUMERS REQUEST AND SUPPORT SAME INVESTIGATIONS INCLUDING. RESULTS OF INCOMING INSPECTIONS OR SIMILAR DOCUMENTS: NO OBSERVATIONS MADE DURING INCOMING INSPECTION FROM BGS FOR THE PRODUCTS. REVIEW OF QUALITY ASSURANCE AGREEMENTS (QSV): THE QSV 63 DEFINES THE AGREEMENT BETWEEN STRYKER AND BGS AS STERILIZATION COMPANY. IN CASE OF DELIVERY OF UNSTERILE PRODUCT REVIEW THE STATUS OR RE-STERILIZATION BY THE COSTUMER: REVIEW OF THE STERILIZATION REQUESTS IN THE INSTRUCTIONS FOR USE (IFU): ALL AFFECTED PRODUCTS WERE DELIVERED IN STERILE CONDITION (GAMMA RADIATION). IN CASE OF RE-STERILIZATION THE REQUIREMENTS IN IFU AND STERILIZATION PROCEDURE SPECIFY STEAM STERILIZATION. IF APPLICABLE, CHECK THE BIO BURDEN OF OTHER SUITABLE PRODUCTS (I.E. SAME PRODUCTION LOT) WHICH MAY BE AVAILABLE IN DIFFERENT WAREHOUSES OR STOCKS. IF RETAIN SAMPLES ARE AVAILABLE, CHECK THE BIO BURDEN. TURBIDITY VERIFICATION ON LIQUIDS, IF APPLICABLE IN ORDER TO SUPPORT THE ROOT CAUSE ANALYSES AND TO EVALUATE THE POSSIBLE RISK TO OTHER PATIENTS. POTENTIALLY AFFECTED PRODUCTS WERE NEITHER ON STOCK NOR WERE ANY RETAIN SAMPLES AVAILABLE THE PRODUCT WAS NOT RETURNED TO STRYKER (B)(4). IT SHOULD BE NOTED THAT NO PHYSICAL FAILURE OF THE PRODUCT IN QUESTION WAS SUBJECT OF THE REPORTED EVENT - PROVIDED X-RAYS HAD REVEALED COMPLETE FUNCTION AFTER AN IMPLANTATION PERIOD OF APPROX. 3 MONTHS - BUT A WOUND INFECTION ISSUE WAS ALLEGED HAVING OCCURRED AFTER AN IMPLANTATION PERIOD OF APPROX. 14 DAYS. BASED ON RECEIVED INFORMATION THAT THE EVENT HAD OCCURRED ROUGHLY 4 YEARS AGO, AND BASED ON THE INFORMATION THAT THE PATIENT HAD BEEN LOST FOR FOLLOW-UP, AND BASED ON THE INFORMATION THAT THE HOSPITAL HAD ASSESSED A RELATIONSHIP TO THE DEVICE AS "PROBABLY NOT" IT WAS DECIDED NOT TO SEND OUT THE CUSTOMER QUESTIONNAIRE / CHECKLIST ACCORDING TO DQF 13-003. WOUND INFECTION WAS MOST LIKELY NOT CAUSED BY UNSTERILE PRODUCTS. IN CASE OF A DEVICE RELATED ISSUE IT COULD BE MORE LIKELY THAT REMAINING PARTS PROBABLY PRODUCED BY INTRA-OPERATIVE DAMAGE MAY HAVE CAUSED ALLEGED WOUND INFECTION. THE ITEM IN QUESTION WAS NOT PACKED UNDER CLEAN ROOM CONDITIONS BUT IN ACCORDANCE TO LOCAL REQUIREMENTS REFERRING TO EU GMP-CLASS D (ANNEX 1) RESP. ISO-CLASS 8 IN A "CONTROLLED AREA". AFTER THE PACKAGING PROCESS THE IMPLANT HAD BEEN EXPOSED TO GAMMA RADIATION FOR STERILIZATION. ACCORDING TO DQF (B)(4) THE DOCUMENTED TEST RESULTS WERE REVIEWED FOR THIS INVESTIGATION AND NO DEVIATION WAS FOUND. INVESTIGATION SUGGESTS THAT THE PRODUCT WAS STERILE AT THE TIME OF DISTRIBUTION. GENERAL TECHNICAL ASPECT: IF THE STERILE BARRIER OF THE PACKAGE IS OPENED OR SUSPECTED BEING IMPAIRED (I.E. TRANSPORT ISSUE OR INSUFFICIENT USAGE IN HOSPITAL) THE IFU INSTRUCT THAT IN THESE CASES THE PRODUCT MUST BE RE-STERILIZED IN CASE OF USE. NONE OF THE REMAINING PRODUCTS WITH THE SAME LOT HAVE BEEN REPORTED TO HAVE CAUSED ANY INFECTION. BASED ON THE REVIEW OF ALL RELEVANT DOCUMENTS FROM THE MANUFACTURER SITE AND ON THE INFORMATION PROVIDED BY THE CUSTOMER NO EVIDENCE FOR A DEVICE RELATED REASON OF THE REFERRED MATTER HAS BEEN FOUND. FURTHERMORE, THE REVIEW OF THE DHR SHOWED THAT THE IMPLANT WAS SUCCESSFULLY STERILIZED WITH GAMMA RADIATION; THEREFORE IT IS GRANTED THAT THE IMPLANTS WERE DELIVERED IN STERILE CONDITION. STERILIZED STRYKER IMPLANTS ARE GRANTED TO BE STERILE FOR FIVE YEARS (AS VISIBLE ON THE LABEL) IF THE PACKAGING IS UNDAMAGED. THE REVIEW OF THE LABELS INDICATED THAT THE IMPLANT WAS USED PRIOR TO ITS EXPIRY DATES AND NO REPORT CONCERNING A DAMAGED PACKAGING OF THE AFFECTED DEVICE HAS BEEN CONVEYED TO STRYKER. THUS, CONTAMINATION AT THE MANUFACTURER'S SITE IS EXCLUDED WITH A PROBABILITY BORDERING ON CERTAINTY. REVIEW OF COMPLAINT HISTORY, CAPA DATABASES AND RISK ANALYSIS DID NOT IDENTIFY ANY CONSPICUITY. THE REVIEW OF THE RISK ASSESSMENT FOR THE FAILURE MODE INDICATED THE ISSUE WAS ADDRESSED ADEQUATELY. THERE ARE NO ACTIONS IN PLACE RELATED TO THE REPORTED EVENT FOR THE SUBJECT PRODUCT. NO NON-CONFORMITY WAS IDENTIFIED. BASED ON LIMITED INFORMATION AND REFERRING TO THAT NO DEVIATION WAS FOUND IN THE MANUFACTURING DOCUMENTS A DEFICIENCY IN THE IMPLANT IN QUESTION WAS NOT VERIFIED. IMPORTANT NOTE FROM THE STUDY CENTER: THE GAMMA3 FOLLOW-UP CLINICAL INVESTIGATION WAS STARTED LONG TIME BEFORE THE REGULAR MEDICAL EXPERT REVIEW OF COMPLICATIONS FROM CLINICAL INVESTIGATIONS WAS IMPLEMENTED. STUDY START WAS APRIL 2005 AND (B)(4) REVISION INCLUDING MEDICAL EXPERT REVIEW WAS FIRST IMPLEMENTED IN Q4 2010. TO CLOSE THE GAP, IT WAS DECIDED TO REVIEW ALL COMPLICATIONS CLASSIFIED AS SAES AND AE BY THE SITE INVESTIGATORS IN ONE GO, BEFORE THE FINAL REPORT CAN BE FINALIZED. WITH THIS IT CAN BE ENSURED, THAT REGARDLESS OF THE INITIAL COMPLICATION CLASSIFICATION FROM THE SITE INVESTIGATORS, NO CASE WAS MISSED TO BE REPORTED (EVEN IF THE DEVICE RELATION IS ONLY A POTENTIAL ONE AND NOT DIRECTLY OBVIOUS). ALL ADVERSE EVENTS CLASSIFIED AS ADE (ADVERSE DEVICE EFFECT) WERE CHECKED AND A PER/PI NUMBER WAS FILED CORRECTLY FOR ALL CASES ((B)(4)). ALL ADVERSE EVENTS CLASSIFIED AS SADE (SERIOUS ADVERSE DEVICE EFFECT) WERE CHECKED AND A PER/PI NUMBER WAS FILED CORRECTLY FOR ALL CASES ((B)(4)). ALL ADVERSE EVENTS CLASSIFIED AS AE (ADVERSE EVENT, NOT SERIOUS AND NOT DEVICE RELATED) WERE CHECKED ((B)(4)) - NO MDR REPORTING NEEDED. THEY WERE CONFIRMED BY MEDICAL EXPERT AS BEING CORRECT ON (B)(6) 2014 - ALL ADVERSE EVENTS CLASSIFIED AS SAE (SERIOUS ADVERSE EFFECT) WERE CHECKED ((B)(4)) -> AFTER THE MEDICAL EXPERT REVIEW, (B)(4) CASES INITIALLY CLASSIFIED AS SAE SHOULD BE REPORTED AS SADE, DUE TO THE FACT THAT THE DEVICE RELATION CANNOT BE FULLY EXCLUDED! THIS EVENT WAS INITIALLY REPORTED UNDER THE ASPECTS OF MEDDEV 5.1.1.IN CASE RELEVANT CLINICAL INFORMATION SHOULD BECOME AVAILABLE, WE RESERVE THE RIGHT TO UPDATE THE INVESTIGATION AND CHANGE THE ROOT CAUSE.

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE INVESTIGATORS REPORTED VIA A REVIEW OF ADVERSE EVENTS FOR THE GAMMA 3 FOLLOW UP STUDY THAT PATIENT (B)(6) ALLEGEDLY HAD A WOUND INFECTION ON (B)(6) 2010 FOLLOWING IMPLANTATION WITH A TROCHANTERIC NAIL KIT ON (B)(6) 2010.

    Description of Event or Problem · 1

    THE INVESTIGATORS REPORTED VIA A REVIEW OF ADVERSE EVENTS FOR THE GAMMA 3 FOLLOW UP STUDY THAT PATIENT 05-0156 ALLEGEDLY HAD A WOUND INFECTION ON (B)(6) 2010 FOLLOWING IMPLANTATION WITH A TROCHANTERIC NAIL KIT ON (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616275 TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X180MM X 130° ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB STRYKER TRAUMA KIEL K110544

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention