BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1ST MTP FUSION PL 2.4/2.7 VA LOCK MED L5

    MDR report key: 2973818 · Received February 22, 2013

    Report

    Report Number
    1719045-2013-00406
    Event Type
    Malfunction
    Date Received
    February 22, 2013
    Report Date
    January 25, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    K100776
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A REVIEW OF THE DHR SHOWS NO COMPLAINT RELATED ANOMALIES. ALL OF THE SAMPLE LABELING AS WELL AS ALL OTHER RELATED DOCUMENTATION INCLUDING INSPECTION DOCUMENTATION ALL INDICATED A LEFT PLATE.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. ADDITIONAL INFORMATION. THE REVIEW HAS SHOWN THAT THE LONG TEXT DESCRIPTION IS INDEED INCORRECTLY MARKED WITH RIGHT INSTEAD OF LEFT. THIS IS A LABELING FAULT, WHICH WAS MADE IN THE LABEL MASTER DOCUMENT OF THIS ARTICLE AND WAS REGRETTABLY NOT DETECTED DURING THE RELEASE OF THIS DOCUMENT. THIS COMPLAINT WAS FORWARDED TO OUR POST MARKET RISK MANAGEMENT GROUP TO DEFINE THE RISK OF THIS FAULT AND IF FURTHER ACTIONS ARE NECESSARY. A CAPA HAS BEEN OPENED TO ADDRESS THIS COMPLAINT EVENT.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING A VA FOOT PROCEDURE IN THE (B)(6) ON (B)(6) 2013, IT WAS NOTED THAT THE LABEL ON THE 1ST MTP FUSION PLATE WAS INCORRECT. REPORTEDLY ON THE FRONT OF THE PRODUCT IS LABELED LEFT BUT THE BACK IS LABELED RIGHT. IT WAS REPORTED THIS HAD NO REAL NEGATIVE IMPACT ON THIS PATIENT BECAUSE THE CODE OF IMPLANT IN THE BOX MATCHED THE CODE ON THE FRONT OF THE BOX WHICH WAS WHAT THE SURGEON REQUESTED. THE INCIDENT DID NOT HAVE ANY SIGNIFICANT IMPACT ON THE DURATION OF SURGERY. IT JUST DELAYED OPENING OF THE IMPLANT BOX BY A FEW MINUTES WHILE A CROSS CHECKED OF THE CODES WAS BEING CONDUCTED TO MAKE SURE THE CORRECT IMPLANT WAS BEING IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78198 1ST MTP FUSION PL 2.4/2.7 VA LOCK MED L5 FUSION PLATE HSB SYNTHES MONUMENT 6573410

    Patients

    Seq Age Sex Outcome Treatment
    1