BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUBTALAR MBA IMPLANT, 12MM

    MDR report key: 5896062 · Received August 23, 2016

    Report

    Report Number
    3004608878-2016-00221
    Event Type
    Injury
    Date Received
    August 23, 2016
    Report Date
    July 28, 2016
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    HWC
    PMA / PMN Number
    K960692
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED 31AUG2016: THE SALES REPRESENTATIVE FOR THIS CASE WORKED FOR THE DISTRIBUTOR, NOT INTEGRA. THE INTEGRA REGIONAL SALES MANAGER PROVIDED INSTRUCTION AND PERMISSION TO STERILIZE THE PRODUCT OUT OF THE PACKAGE. THERE WILL BE NO REVISION SURGERY NOR REMOVAL OF THE IMPLANT. INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON 23SEP2015. THE ADDITIONAL INVESTIGATION ACTIVITIES INCLUDED: METHODS: EVALUATION OF ACTUAL DEVICE. REVIEW OF DEVICE HISTORY RECORDS. REVIEW OF COMPLAINT HISTORY. RESULTS: A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR P/N 050112 REVEALED THAT (B)(4) STERILE MBA IMPLANTS WERE SENT TO SPECIAL TEAM MEDICAL SERVICES UNDER WORK ORDER (B)(4) TO BE RE-PACKAGED AND RE-STERILIZED. WORK ORDER (B)(4) IDENTIFIED THE IMPLANTS AS COMING FROM SUPPLIER LOT # GT0103. THE RE-STERILIZED IMPLANTS WERE RETURNED TO ILS (B)(4) ON DECEMBER 7, 2010, INSPECTED (N = 8) AND RELEASED INTO FINISHED GOODS INVENTORY ON DECEMBER 9, 2010. THERE WERE NO MRRS OR VARIANCES ASSOCIATED WITH THIS PRODUCT LOT. BASED ON EXISTING PROCEDURES AT THAT TIME, THE LOT CODE PRINTED ON THE PRODUCT LABEL WAS 088946, FOR TRACEABILITY TO THE WORK ORDER. A QUERY WAS PERFORMED TO IDENTIFY OTHER COMPLAINTS ASSOCIATED WITH EXPIRED IMPLANTS THAT WERE SENT TO, OR USED BY A HOSPITAL. THE QUERY WAS LIMITED TO ORTHOPEDIC, TISSUE AND TECHNOLOGIES (OTT) RECONSTRUCTIVE IMPLANTS AND COVERED THE PAST 24 MONTHS. THE QUERY IDENTIFIED FOUR ADDITIONAL COMPLAINTS. INCLUDING THIS COMPLAINT, INTEGRA HAS RECEIVED AND CONFIRMED A TOTAL OF FIVE COMPLAINTS OVER THE PAST 24 MONTHS IN WHICH A NON-STERILE ORTHOPEDIC DEVICE HAS BEEN IMPLANTED. A FAILURE ANALYSIS, BASED ON THE NUMBER OF SOLD DEVICES, WASN¿T CALCULATED BUT A REVIEW OF THE ILS (B)(4) DECONTAMINATION RECORDS REVEALED THAT (B)(4) KATALYST, KOMPRESSOR, MBA, FREEDOM WRIST, UNIVERSAL2, TITANIUM BONE WEDGE, SALTO TALARIS ANKLE, CADENCE ANKLE, REVERSE SHOULDER AND PANTA INSTRUMENT SETS HAVE BEEN RETURNED AND PROCESSED OVER THE PAST 24 MONTHS. ALL OF THESE SETS REQUIRE INDIVIDUALLY PACKAGED AND STERILIZED IMPLANTS. THE TOTAL NUMBER OF CUSTOMER COMPLAINTS VERSUS THE NUMBER OF OPPORTUNITIES IS WELL BELOW THE THRESHOLD ESTABLISHED IN PRODUCT RISK MANAGEMENT FOR REQUIRING CORRECTIVE ACTION. CONCLUSION: BASED ON THE INFORMATION THAT WAS PROVIDED FROM THE COMPLAINANT, INTEGRA WAS ABLE TO CONFIRM THAT EXPIRED PRODUCT WAS PROVIDED BY A DISTRIBUTOR TO A HOSPITAL. HOSPITAL PERSONNEL DECIDED TO RE-STERILIZE THE IMPLANT BASED ON INSTRUCTIONS PROVIDED BY INTEGRA. THE ROOT CAUSE FOR THIS COMPLAINT WAS A BREAKDOWN IN THE INSPECTION PROCESS OF EXISTING INVENTORY BY THE DISTRIBUTOR.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE WAS USED FOR A PROCEDURE. IT IS IMPLIED THE DEVICE WAS USED BEYOND THE EXPIRY DATE. THE DATE OF THE PROCEDURE/IMPLANTATION HAS NOT BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    548432 SUBTALAR MBA IMPLANT, 12MM N/A HWC INTEGRA LIFESCIENCES CORPORATION OH/USA 088946

    Patients

    Seq Age Sex Outcome Treatment
    1 Other