BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MATRIX ANATOMIC L-PL MED 3+3HO REVERSIBL

    MDR report key: 3120159 · Received May 20, 2013

    Report

    Report Number
    8030965-2013-02278
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 22, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    JEY
    PMA / PMN Number
    K083388
    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. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS THE MEASURABLE DIMENSIONS OF THE MATRIX ANATOMIC L-PLATE WERE CHECKED AS FAR AS POSSIBLE AND FOUND TO BE IN COMPLIANCE WITH THE TECHNICAL DRAWINGS AND AO/ASIF SPECIFICATION. THE EXAMINATION OF THE RAW-MATERIAL CERTIFICATES AND THE MANUFACTURING PAPERS SHOWED NO DEVIATIONS REGARDING MATERIAL ANALYSIS, STRENGTH AND STRUCTURAL STABILITY. THE MICROSCOPIC VIEW OF THE BROKEN SURFACE IS HOMOGENOUS AND DOES NOT SHOW ANY ANOMALIES. BASED ON THESE FINDINGS WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON CONFORMANCES. IT IS VISIBLE THAT THE PLATE WAS STRONGLY BENT IN DIFFERENT DIRECTIONS BEFORE IT BROKE. EXCESSIVE BENDS IN DIFFERENT DIRECTIONS MAY HAVE CAUSED THIS BREAKAGE. IN THIS RELATION WE WOULD LIKE TO POINT OUT THAT REVERSE BENDS SHOULD BE AVOIDED AS THIS MAY WEAKEN THE PLATE AND LEAD TO PREMATURE IMPLANT FAILURE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING AN UNSPECIFIED SURGERY ON (B)(6) 2013, REPORTEDLY THE PLATE BROKE OFF. NO FURTHER INFORMATION WAS PROVIDED. THIS IS 1 OF 1 REPORT FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222510 MATRIX ANATOMIC L-PL MED 3+3HO REVERSIBL JEY SYNTHES GMBH 3226343

    Patients

    Seq Age Sex Outcome Treatment
    1