BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REDUC-FORCEPS TOOTHED RATCH-LOCK L140

    MDR report key: 3173889 · Received June 17, 2013

    Report

    Report Number
    8030965-2013-03186
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Report Date
    November 9, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE ADDITIONAL EVALUATION REVEALED THAT THE FORCEPS BROKEN. THE INVESTIGATION CARRIED OUT SHOWED THAT THE REDUCTION FORCEPS HAD SNAPPED AT THE FRONT ON ONE SIDE. TRACES OF WEAR ARE ALSO VISIBLE ON THE SURFACE. AS THIS INSTRUMENT DATES BACK TO 2005, WE ASSUME THAT THIS BREAK IS THE RESULT OF MECHANICAL OVERLOAD OVER THE YEARS. NO INDICATION OF A MATERIAL OR MANUFACTURING ERROR WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE REDUCTION FORCEPS ARE BROKEN. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272951 REDUC-FORCEPS TOOTHED RATCH-LOCK L140 HTD SYNTHES GMBH 1369145

    Patients

    Seq Age Sex Outcome Treatment
    1