BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERNAL CABLE Ø1 W/NEEDLE+FIXATION SLEEV

    MDR report key: 3488712 · Received November 26, 2013

    Report

    Report Number
    8030965-2013-05345
    Event Type
    Malfunction
    Date Received
    November 26, 2013
    Date of Event
    October 25, 2013
    Report Date
    November 4, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    JDQ
    PMA / PMN Number
    K031508
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE MANUFACTURING EVALUATION REPORTED THE COMPLAINT CONDITION (UNABLE TO SEPARATE NEEDLE FROM CABLE) PERTAINS TO THE COMPONENT 291.916.1 AND IS DUE TO AN UNKNOWN CAUSE. THE 291.916.01S ASSEMBLY INITIALLY CONFORMED TO ALL REQUIREMENTS AND WAS INSPECTED AND CONFORMED TO THE SYNTHES INSPECTION REQUIREMENTS. THE MANUFACTURING EVALUATION DID NOT REPORT ANY FAULT OF THE MANUFACTURING PROCESS FOR THE COMPLAINED EVENT. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    PRODUCT DEVELOPMENT EVALUATION WAS CONDUCTED. THE REPORT INDICATES THAT FOUR CABLES RECEIVED. IT WAS FOUND THAT THE NEEDLES COULD NOT BE REMOVED WITH FORCEPS AS PER THE DESIGN INTENT. SOME OF THE NEEDLES HAVE CLEAR MARKS FROM THE FORCEPS USED DURING THE ATTEMPT OF NEEDLE REMOVAL. NO DESIGN RELATED ROOT CAUSE CAN BE IDENTIFIED ON THE RETURNED DEVICES, THE COMPLAINT IS INDETERMINATE FROM A DESIGN PERSPECTIVE. THE DEVICE WAS RETURNED ON (B)(4) 2013.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE DEVICE HISTORY REVIEW (DHR) BY (B)(4) COMPLETED ON (B)(4) 2013 REPORTED NO COMPLAINT RELATED ISSUES WERE FOUND. IN ADDITION THE DHR REVEALED THE DEVICE WAS MANUFACTURED ON 12/8/2010 AND HAD AN EXPIRATION DATE OF 11/1/2020. THE DEVICE HISTORY REVIEW RELEVANT TO AFTER THE DEVICE WAS ASSEMBLED COMPLETED BY (B)(4) ON (B)(4) 2014 REPORTED: SYNTHES (B)(4) ASSEMBLED THE 1.0MM STERNAL CABLE WITH NEEDLE - STERILE, P/N 291.916.01S, AND LOT NUMBER 6472188) FOR WORK ORDER (B)(4), FROM LOT NUMBER 6261290 OF COMPONENT 291.916.1 AND LOT NUMBER 6221302 OF COMPONENT 291.906.1. BOTH COMPONENTS WERE MANUFACTURED BY DANIELS MANUFACTURING. LOT 6221302, OF COMPONENT 291.906.1 CONFORMED TO ALL REQUIREMENTS (C OF C DATE 9/22/09) AND WAS RELEASED FOR ASSEMBLY 9/29/09. LOT 6261290, COMPONENT 291.916.1 CONFORMED TO ALL INSPECTION REQUIREMENTS (C OF C DATE 12/18/09) AND WAS RELEASED FOR ASSEMBLY 2/3/10. THE COMPONENTS WERE ASSEMBLED AND INSPECTED TO SYNTHES INSPECTION SHEET NS025211, REVISION A (DATED 9/1/10). THERE WERE NO NON-CONFORMANCES OR OTHER COMPLAINT-RELATED ISSUES ASSOCIATED WITH THIS COMPLAINT. THE FINAL ASSEMBLY WAS RELEASED TO FINISHED GOODS 9/10/10. IN ADDITION THE DHR REVEALED THE DEVICE WAS MANUFACTURED ON 09/13/2010 AND HAD AN EXPIRATION DATE OF 08/31/2019 THE FINAL ASSEMBLY OF THE PART WAS PERFORMED AT (B)(4), THE COMPONENTS WERE STERILIZED BY (B)(4) THEREFORE TWO DHR¿S WERE PERFORMED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2013, DURING AN UNKNOWN SURGERY THAT THE NEEDLE COULD NOT BE SEPARATED FROM THE CABLES. THE PROPER SEPARATION TECHNIQUE WAS ATTEMPTED AND WAS UNSUCCESSFUL. SUBSTANTIAL FORCE WAS USED IN ATTEMPTING TO SEPARATE THE NEEDLE FROM THE CABLES BUT WAS ALSO UNSUCCESSFUL. THE STOCK AVAILABLE INCLUDED CABLES IN WHICH THE NEEDLE COULD BE REMOVED THE NORMAL WAY, THEREFORE, THE SURGERY COULD PROCEED AS INTENDED. THIS IS REPORT 3 OF 4 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CABLES USED TO COMPLETE THE SURGERY WERE FROM THE SAME LOT AS THE CABLES THAT DID NOT WORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616634 STERNAL CABLE Ø1 W/NEEDLE+FIXATION SLEEV JDQ SYNTHES GMBH 2672682

    Patients

    Seq Age Sex Outcome Treatment
    1