BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIB HOOK

    MDR report key: 3121818 · Received May 21, 2013

    Report

    Report Number
    2530088-2013-00812
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Report Date
    March 4, 2011
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    MDI
    PMA / PMN Number
    H03009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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. (B)(6). THE DHR WAS REVIEWED AND NO ISSUES THAT WOULD HAVE RESULTED IN THIS COMPLAINT WERE FOUND. THE ADDITIONAL EVALUATION VISUAL INSPECTION REVEALED THAT THE POLYAXIAL SCREW HEAD IS JAMMED. THE PRODUCTION AND MATERIAL DOCUMENTATION SHOW THAT THE PRODUCTION MEETS ALL SPECIFICATIONS. IN ADDITION, IT WAS DETECTED THAT THE CLOSING CONE WAS COMPLETELY DESTROYED, WHICH DISABLED AND HINDERED THE POLYAXIAL MOVEMENT. IT IS IMPOSSIBLE TO DETERMINE WHETHER THIS HAPPENED WHILE USING THE SCREW OR WHILE TRYING TO REMOBILIZE IT. NO PRODUCTION ERROR WAS ESTABLISHED. THIS PART WAS MANUFACTURED ACCORDING TO THE SPECIFICATIONS. NO PRODUCTION ERROR WAS ESTABLISHED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIB HOOK BROKE DURING SURGERY. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224379 RIB HOOK MDI SYNTHES BRANDYWINE 6322537

    Patients

    Seq Age Sex Outcome Treatment
    1