BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAL SPACER HANDLE

    MDR report key: 3252019 · Received July 29, 2013

    Report

    Report Number
    2520274-2013-04661
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Date of Event
    July 8, 2013
    Report Date
    July 8, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HTD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A MANUFACTURING EVALUATION WAS CONDUCTED. THE UNIT RETURNED FOR THE COMPLAINT MET MATERIAL AND HARDNESS REQUIREMENTS AS WELL AS THE DIAMETER AT THE TIP. THE THREADS COULD NOT BE MEASURED BECAUSE THEY ARE BROKEN. BASED ON THE SPECIFICATIONS AT THE TIME OF THE ORIGINAL MANUFACTURING, THE UNKNOWN ROOT CAUSE, AND THE EVALUATION PERFORMED BY SYNTHES, THIS COMPLAINT IS DEEMED INVALID FROM A MANUFACTURING POSITION. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A PRODUCT DEVELOPMENT EVENT EVALUATION WAS CONDUCTED. THE TRIAL HANDLE IS FOUND IN THE SYNFIX LR TECHNIQUE GUIDE. IT IS USED TO INSERT THE TRIAL SPACER INTO THE DISC SPACE TO ASSIST IN DETERMINING THE PROPER SIZE IMPLANT. THE BROKEN PORTION OF THE TRIAL INSERTER CANNOT BE REMOVED FROM THE TRIAL FOR FURTHER EVALUATION. THE TRIAL SPACER INSERTER IS WHAT FAILED DURING THE PROCEDURE. BASED ON THE MANUFACTURING EVALUATION, THE FRACTURED SPINDLE IS 440A WHICH WAS MADE PRIOR TO THE MATERIAL CHANGE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. A REVIEW OF THE DEVICE HISTORY RECORDS WAS NOT PERFORMED BECAUSE NO LOT NUMBER WAS PROVIDED AND IT WAS NOT AVAILABLE ON THE RETURNED PRODUCT. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THE FOLLOWING EVENT HAPPENED DURING AN L4-S1 DISC REPLACEMENT PROCEDURE. AFTER THE DISC REMOVAL, THE SURGEON USED THE SYNFIX 26X32X12MM 12 DEG IMPLANT TRIAL TO SIZE THE DISC SPACE. HE USED A MALLET TO TAP THE TRIAL DIRECTLY TO THE POSTERIOR WALL. AFTER SEVERAL ATTEMPTS TO MALLET THE TRIAL TO THE BACK OF THE DISC SPACE, THE INSERTER BROKE OFF IN THE TRIAL. THE SURGEON USED A CURETTE TO REMOVE THE TRIAL. THE TRIAL WAS REMOVED, AND THE IMPLANT WAS SUCCESSFULLY IMPLANTED. THE ESTIMATED TIME DELAY WAS 3 MINUTES. THE PATIENT REPORTEDLY WAS NOT HARMED BY THE BROKEN INSERTER. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352960 TRIAL SPACER HANDLE HTD SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR