BEUDAMED
    FDA Adverse Event Other Summary report: N

    HEMICAP FIXATION COMPONENT

    MDR report key: 2858079 · Received November 26, 2012

    Report

    Report Number
    3004154314-2012-00003
    Event Type
    Other
    Date Received
    November 26, 2012
    Date of Event
    March 5, 2010
    Report Date
    November 19, 2012
    Manufacturer
    ARTHROSURFACE, INC.
    Product Code
    HSD
    PMA / PMN Number
    K023096
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ALL PRODUCT WAS SUCCESSFULLY RETURNED BACK IN 2010. THE CAPA AND ASSOCIATED ACTION ITEMS ARE CLOSED.

    Description of Event or Problem · 1

    BACK IN (B)(6) 2010, TWO CUSTOMER COMPLAINTS WERE RECEIVED INDICATING THE WRONG SIZE PIN WAS FOUND IN THE SCREW ASSEMBLY. FOLLOWING A THOROUGH INVESTIGATION AT THE CONTRACT MANUFACTURER, IT IS BELIEVED THE PINS WERE SWITCHED DURING THE PACKAGING PROCESS. LOT HISTORY RECORDS SHOW THAT BOTH LOTS OF PRODUCT WERE PRODUCED ON THE SAME DAY. THE (B)(4) PIECES OF EACH LOT WAS PRODUCED. AFFECTED PRODUCT: MODEL NUMBER 8135-1875-W, LOT 75J12718, 13.7 MM FIXATION COMPONENT, WAS PACKAGED WITH 2.0 MM DIAMETER GUIDE PIN; SHOULD HAVE BEEN 2.5 MM GUIDE PIN. MODEL NUMBER 7095-0020-W, LOT 75J12714, 9.5 MM FIXATION COMPONENT, WAS PACKAGED WITH 2.5 MM DIAMETER GUIDE PIN; SHOULD HAVE BEEN 2.0 MM GUIDE PIN. ALL AVAILABLE PRODUCT FROM BOTH LOTS WAS RETURNED FROM THE FIELD. A FULL NOTIFICATION ASSESSMENT WAS PERFORMED AT THE TIME AND DOCUMENTED AS PART OF CAPA (B)(4). THE ISSUE WAS DOCUMENTED AS NOT REPORTABLE TO THE FDA ACCORDING TO THE REQUIREMENTS LISTED IN 21 CFR 803.10 (A). BASED ON OUR UNDERSTANDING OF 21 CFR 806, THE ACTION WAS NOT INITIATED TO: REDUCE A RISK TO HEALTH POSED BY THE DEVICE. REMEDY A VIOLATION OF THE ACT CAUSE BY THE DEVICE WHICH MAY PRESENT A RISK TO HEALTH. THERE WAS NO HARM TO THE PATIENT OR USER AND NO ADDITIONAL RISK TO HEALTH WAS PRESENTED AS A RESULT OF THE ISSUE. FOR THE 2.0 MM GUIDE PIN PACKAGED INSTEAD OF THE 2.5 MM GUIDE PIN, THERE WAS ADDITIONAL CLEARANCE WITH THE MATING DRILL GUIDE AND THE CASE WAS COMPLETED WITHOUT ISSUE. FOR THE 2.5 MM GUIDE PIN PACKAGED INSTEAD OF THE 2.0 MM GUIDE PIN, ANOTHER PACKAGE NEEDED TO BE OPENED, BUT THE CASE WAS COMPLETED WITHOUT ISSUE. BECAUSE NO ADDITIONAL RISK IS PRESENTED, THE ISSUES HAVE BEEN DEFINED AS A MINOR VIOLATION OF THE ACT AND THEREFORE THE ACTION IS CONSIDERED A MARKET WITHDRAWAL AS DEFINED IN 803.5 (H). PURSUANT TO SECTION 21 CFR 803.10 (B) (2), MARKET WITHDRAWALS ARE EXEMPT FOR THE REPORTING REQUIREMENTS. PER A RECENT 483 OBSERVATION, IT WAS DEEMED BY (B)(4) THAT THIS ISSUE SHOULD HAVE BEEN REPORTED TO FDA. IN ACCORDANCE WITH THE OBSERVATION, FDA MEDWATCH FORM 3500A HAS RECENTLY HAVE COMPLETED AND FILED. THE CAPA AND ASSOCIATED ACTIONS ARE CLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMICAP FIXATION COMPONENT NONE HSD ARTHROSURFACE, INC. 7095-0020/8135-1875 75JI2714/75JI2718

    Patients

    Seq Age Sex Outcome Treatment
    1