BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BEND-IRON F/RECOPL 3.5+4.5 L190

    MDR report key: 3192964 · Received June 27, 2013

    Report

    Report Number
    8030965-2013-03652
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Report Date
    March 27, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXP
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HR
    Reporter Occupation
    OTHER

    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. THE DHR WAS REVIEWED AND NO ISSUES THAT WOULD HAVE RESULTED IN THIS COMPLAINT WERE FOUND. OUR INVESTIGATION HAS SHOWN THAT ONE PIN OF THE COMPLAINED BENDING IRON IS INDEED BROKEN OFF. WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE WHICH HAS LED TO THIS BREAKAGE. THE BROKEN SURFACE OF THE INSTRUMENT IS HOMOGENOUS WHICH INDICATE MATERIAL CONFORMITY WELL. NO PRODUCT FAULT COULD BE DETECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSTRUMENT WAS BROKEN. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294470 BEND-IRON F/RECOPL 3.5+4.5 L190 HXP SYNTHES GMBH T940663

    Patients

    Seq Age Sex Outcome Treatment
    1