BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROD INTRODUCTION PLIERS FOR SIDE-OPENING IMPLANTS

    MDR report key: 2896930 · Received January 4, 2013

    Report

    Report Number
    8030965-2013-00025
    Event Type
    Malfunction
    Date Received
    January 4, 2013
    Date of Event
    December 6, 2012
    Report Date
    December 6, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTC
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. DIENER (B)(4) MANUFACTURED THE ROD INTRODUCTION PLIERS, PART 388.50, LOT NUMBER 5476522, 5520809, AND 5520810, SUPPLIER LOT A7QA10. THE LOT INITIALLY CONFORMED TO SPECIFICATIONS, THERE WAS NO COMPLAINT-RELATED ISSUES WITH THIS LOT, AND WAS INSPECTED AND CONFORMED TO THE SYNTHES INSPECTION SHEET. THE COMPLAINT CONDITION IS DUE TO AN UNKNOWN CAUSE. THE PART EXHIBITS MINOR SCRATCHES AND NICKS, ESPECIALLY ON THE COLLET COMPONENT PART 388.50.4. THE ROD INTRODUCTION PLIERS WERE MANUFACTURED TO THE SYNTHES SOURCE CONTROL DRAWING.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. INFORMATION RECEIVED FROM CONSULTANT. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. PLACEHOLDER.

    Description of Event or Problem · 1

    THIS IS 2 OF 3 REPORTS FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    THE SALES CONSULTANT REPORTED: THE ROD HOLDING FORCEPS: THE BAR IN THE CENTER OF THE ROD HOLDER THAT KEEPS THE HANDLES INTACT, BROKE IN HALF ALSO DURING THE PROCEDURE.

    Description of Event or Problem · 1

    ON (B)(6) 2012, SURGEON WAS CORRECTING A DEFORMITY USING A ROD INTRODUCTION PLIER. THE PLUNGER FELL OFF THE PLIER AND THE BARREL WAS TWISTING. THE SURGEON USED ANOTHER ROD INTRODUCTION PLIER, BUT THE PLUNGER WAS COMING LOOSE AND HE WAS UNABLE TO TIGHTEN THE SCREW. HE WAS ABLE TO FINISH THE PROCEDURE WITH A THIRD SET. THE SURGERY WAS PROLONGED ABOUT 10 MINUTES. THIS IS 2 OF 3 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4690 ROD INTRODUCTION PLIERS FOR SIDE-OPENING IMPLANTS INTRODUCTIONS PLIER HTC SYNTHES GMBH A7QA10

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR FORCEPS