BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL TI RIB HOOK

    MDR report key: 2986453 · Received February 26, 2013

    Report

    Report Number
    2530088-2013-10151
    Event Type
    Malfunction
    Date Received
    February 26, 2013
    Date of Event
    April 20, 2011
    Report Date
    April 20, 2011
    Manufacturer
    SYNTHES (USA) BRANDYWINE
    Product Code
    MDI
    PMA / PMN Number
    H03009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    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. MANUFACTURING EVALUATION REVEALED THE SAMPLE WAS RECEIVED BROKEN IN TWO PIECES WHERE THE LOWER TAB IS BROKEN OFF FROM THE MAIN BODY. VISUAL INSPECTION NOTED SEVERAL NICKS AND DENTS WERE NOTED ON VARIOUS SURFACES AS A RESULT OF USE. MEASURABLE DIMENSIONS WERE FOUND WITHIN SPECIFICATION. THE COMPLAINT IS DEEMED INVALID FROM A MANUFACTURING STANDPOINT. PRODUCT DEVICE EVALUATION REVEALED THE RIB HOOK SHOWS MARKINGS IN THE SLOT FEATURE WHICH MATES WITH THE RIB HOOK CAP. THE FLANGE ON THE ROB HOOK HAS BROKEN OFF THE BODY OF THE RIB HOOK INDICATING FAILURE DUE TO EXCESSIVE BENDING OR "LEVERING" WITHIN THE RIB HOOK SLOT. THIS WOULD ALSO CORROBORATE THE MARKINGS FOUND ON THE INSIDE OF THE RIB HOOK SLOT. THE FINAL ASSEMBLY PROCEDURE OF THE RIB HOOK AND RIB HOOK CAP CAN CREATE THIS TYPE OF SCENARIO WHERE THE CAP IS FORCED INTO THE RIB HOOK IN ORDER TO ENCIRCLE THE RIB. IT CANNOT BE DETERMINED IF THE SMALL RIB HOOK FLANGE WAS BROKEN OFF PRIOR OR DURING SURGERY, HOWEVER, WEAR MARKINGS ON THE IMPLANT USAGE OF THE RIB HOOK. THE COMPLAINT IS DEEMED INVALID FROM A MANUFACTURING STANDPOINT. A REVIEW OF DEVICE HISTORY RECORD DID NOT REVEAL ANY CONDITIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A VERTICAL EXPANDABLE PROSTHETIC TITANIUM RIB (VEPTR) PROCEDURE, THE RIB HOOK BROKE IN SITU. SURGEON SELECTED ANOTHER HOOK AND COMPLETED THE PROCEDURE. THIS IS 2 OF 2 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81267 SMALL TI RIB HOOK MDI SYNTHES (USA) BRANDYWINE 6548643

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR