BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEN Ø3.5 L440 TAN LIGHT BLUE

    MDR report key: 2891253 · Received December 31, 2012

    Report

    Report Number
    8030965-2012-01721
    Event Type
    Malfunction
    Date Received
    December 31, 2012
    Date of Event
    November 11, 2012
    Report Date
    December 3, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTY
    PMA / PMN Number
    K971783
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT IDENTIFIER REPORTED AS (B)(6). SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. OUR INVESTIGATION HAS SHOWN THAT THE RETURNED TEN CUTTER IS INDEED BROKEN OFF. THE WELDED CONNECTION IS BROKEN OFF. IT WAS ALSO VISIBLE, AFTER DISMANTLING OF THE CUTTER, THAT THE CUTTING EDGES ARE DAMAGED AND BLUNT. THIS LEAD US BELIEVE THAT UNDER THESE CIRCUMSTANCES IT WAS NOT POSSIBLE TO CUT THE TEN NAIL ACCORDINGLY. THE PRESENT LOT WAS MANUFACTURED AND SOLD IN THE YEAR 2007, OCTOBER. ACCORDING TO THE SPECIFICATIONS AND WE ARE NOT AWARE OF ANY QUALITY FAILURES. SINCE NO MANUFACTURING RELATED CONDITION WAS FOUND AND THE PRESENT CUTTING BOLT IS QUIT BLUNT, ALSO HANDLES ARE VERY WORN, WE DETERMINE THIS OCCURRENCE AS NORMAL WEAR AND TEAR OVER THE YEARS.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM SYNTHES (B)(4) PROVIDES INFORMATION FROM A FACILITY IN (B)(6)REGARDING A TITANIUM ELASTIC NAIL. IT WAS REPORTED THAT THE NAIL BROKE. THE DETAILS OF THE BREAKAGE WERE NOT PROVIDED. PATIENT IMPACT AND INVOLVEMENT, UNKNOWN. THIS IS REPORT # 2 OF 3 FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TEN Ø3.5 L440 TAN LIGHT BLUE TEN NAIL HTY SYNTHES GMBH 5917653

    Patients

    Seq Age Sex Outcome Treatment
    1