BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MATNEU SCR Ø1.5 SELF-DRILL L5 TAN

    MDR report key: 3220891 · Received July 11, 2013

    Report

    Report Number
    2520274-2013-04211
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Date of Event
    March 6, 2013
    Report Date
    June 19, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    JEY
    PMA / PMN Number
    K042365
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL EVALUATION WAS CONDUCTED. THE REPORT INDICATES THE MEASURABLE DIMENSIONS OF THE BROKEN SCREW WERE FOUND TO BE IN COMPLIANCE WITH THE TECHNICAL DRAWINGS AND AO/ASIF SPECIFICATION. THE LOT NUMBER IS NOT KNOWN, THEREFORE THE RAW-MATERIAL TESTING CERTIFICATE AND THE MANUFACTURING DOCUMENTS CANNOT BE REVIEWED AND THE PRESENT COMPLAINT CANNOT BE FULLY ANALYZED. AS NO DETAILED CLINICAL INFORMATION IS AVAILABLE, WE CAN SURMISE THAT THERE WAS A TECHNICAL COMPLICATION DURING SURGERY WHICH CAUSED THE BREAKAGE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(4)

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A REVIEW OF THE DEVICE HISTORY RECORDS WAS NOT PERFORMED BECAUSE NO LOT NUMBER WAS PROVIDED AND IT WAS NOT AVAILABLE ON THE RETURNED PRODUCT. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE HEAD OF THE SCREW BROKE OFF DURING INSERTION. ON (B)(6) 2013, THE MATERIAL AND PATIENT INFORMATION WERE RECEIVED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320428 MATNEU SCR Ø1.5 SELF-DRILL L5 TAN JEY SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR