BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T-PAL SMALL TRIAL IMPLANT SIZ 10 NON DET

    MDR report key: 3163644 · Received June 11, 2013

    Report

    Report Number
    8030965-2013-03119
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    June 8, 2012
    Report Date
    June 8, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWT
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    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. (B)(6). THE PRESENT T-PAL TRIAL IMPLANTS AND THE APPLICATOR KNOBS WERE ANALYZED FOR CONFORMANCE TO PRINT SPECIFICATIONS AS WELL AS THE DEVICE HISTORY RECORD WAS RESEARCHED AND NO ABNORMAL FINDINGS WERE IDENTIFIED. MANUFACTURING AND INSPECTION RECORDS INDICATED NO PROBLEMS WITH THE LOT IN QUESTION. OUR ANALYSIS OF THE MATERIAL SHOWS THAT THE BROKEN SURFACE IS HOMOGENOUS AND CONFIRMS THEREFORE ABSOLUTELY TO OUR SPECIFICATIONS. BASED ON THESE FINDINGS WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCES. BASED ON THE PROVIDED INFORMATION WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE. WE CAN ONLY SUPPOSE THAT STRONG HAMMERING DURING THE SURGERY HAS FINALLY LED TO THE BREAKAGE OF THE T-PAL TRIAL IMPLANT-SHAFT TIP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A THREE LEVEL T-PAL PROCEDURE, THE 10 MM TRIAL IMPLANT COULD NOT BE REMOVED FROM THE APPLICATOR. IT WAS NOTED THAT THE KNOB OF THE TRIAL IMPLANT HAD BROKEN INSIDE OF THE APPLICATOR. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264236 T-PAL SMALL TRIAL IMPLANT SIZ 10 NON DET HWT SYNTHES GMBH 7517641

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR