BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BENDING IRON-RIGHT FOR 6.0MM RODS

    MDR report key: 3121517 · Received May 21, 2013

    Report

    Report Number
    8030965-2013-02297
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    April 23, 2013
    Report Date
    April 23, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTC
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. NO IRREGULARITIES WERE FOUND DURING THE DEVICE HISTORY RECORD REVIEW.

    Description of Event or Problem · 1

    DURING AN INITIAL VEPTR IMPLANT SURGERY ON (B)(6) 2013, WHILE BENDING THE ROD IN SITU, THE TIP OF THE BENDING IRON BROKE OFF IN THE PATIENT. THE BROKEN PIECE WAS RETRIEVED. THE SURGEON USED A SIMILAR BENDER FROM A COMPETITORS SET TO COMPLETE THE PROCEDURE WITH NO FURTHER PROBLEMS. THERE WAS NO HARM TO THE PATIENT, AND NO DELAY IN THE PROCEDURE DUE TO THE BROKEN INSTRUMENT REPORTED. THIS IS 1 OF 1 REPORT FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224635 BENDING IRON-RIGHT FOR 6.0MM RODS HTC SYNTHES GMBH A7RA07

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR