BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.4/2.7MM VA-LCP BENDING PLIER

    MDR report key: 3091584 · Received May 3, 2013

    Report

    Report Number
    8030965-2013-02096
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 4, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTC
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: DEVICE MANUFACTURE DATE: 11/12/2010. A MANUFACTURING EVALUATION WAS PERFORMED AND THE REPORT STATES THE FOLLOWING: AN INSPECTION OF THE FRONT PIN WAS NOT POSSIBLE AS IT WASN'T RETURNED; HOWEVER, AS BOTH PINS ARE MACHINED AT THE SAME TIME WE CONCLUDE THAT BOTH ARE DIMENSIONALLY THE SAME. AN INSPECTION OF THE SECOND PIN IN BOTH WIDTHS REVEALS THAT THE PINS ARE DIMENSIONALLY CONFORMING. A HARDNESS TEST WAS CARRIED OUT AND REVEALED THAT THE JAW IS APPROXIMATELY 1HRC OVER THE MAXIMUM LIMIT AT 56HRC. THE HARDNESS TEST AT THE TIME OF MANUFACTURE SHOWED A HARDNESS OF 55 HRC. IN THE MEANTIME THE DEVICE HAS AGED APPROXIMATELY 3 YEARS AND IT CANNOT BE EXACTLY DETERMINED IF THAT CAN AFFECT THE HARDNESS. IT APPEARS THAT THE DEVICE BROKE DUE TO MISUSE, BUT NEVERTHELESS WE CAN ONLY CONCLUDE THIS COMPLAINT TO BE INDETERMINATE. PLACEHOLDER.

    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. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(6).

    Description of Event or Problem · 1

    THIS IS 1 OF 1 DEVICE FOR THIS EVENT ON COMPLAINT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGERY ON (B)(6) 2013, A PLATE BENDER HAD THE TEETH FROM THE END BREAK OFF WHILE IN USE. THERE WAS NO DELAY IN SURGERY OR ADVERSE EVENT TO THE PATIENT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193716 2.4/2.7MM VA-LCP BENDING PLIER HTC SYNTHES GMBH T949964

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR