BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORONAL ROD BENDER-LEFT FOR 5.5MM RODS

    MDR report key: 3053359 · Received April 11, 2013

    Report

    Report Number
    8030965-2013-10814
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 17, 2012
    Report Date
    March 17, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. A REVIEW OF DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES. PRODUCT DEVELOPMENT EVALUATION OBSERVED THAT TIP OF THE BENDER WAS BROKEN OFF AND THE BROKEN PIECE WAS NOT RETURNED. THE BREAK WAS ON THE TIP CLOSEST TO THE HANDLE, WHERE THE SLOT TRANSITIONS TO THE RADIUS WHICH FITS AROUND THE ROD WHEN IN USE. NO OTHER DAMAGE WAS EVIDENT. (B)(4). CHANGES TO THE MATERIAL AND SLOT GEOMETRY WERE RELEASED IN (B)(4) 2011. THIS DEVICE WAS MANUFACTURED SEPTEMBER 2009 WHICH IS PRIOR TO RELEASE OF THE CHANGES. THIS COMPLAINT IS DEEMED VALID FROM A DESIGN PERSPECTIVE.

    Additional Manufacturer Narrative · 1

    DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING A POSTERIOR SPINAL FUSION PROCEDURE THE SURGEON WAS BENDING THE ROD AND WITH THE CORONAL ROD BENDER. THE TIP OF THE CORONAL ROD BENDER (03.632.040) BROKE OFF. BROKEN FRAGMENT WAS RETRIEVED AND DISCARDED OF BY THE ACCOUNT. SURGEON COMPLIED PROCEDURE WITH NO FURTHER PROBLEMS. NO ADVERSE EFFECT TO PATIENT.

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156415 CORONAL ROD BENDER-LEFT FOR 5.5MM RODS HXW SYNTHES GMBH T935338

    Patients

    Seq Age Sex Outcome Treatment
    1