BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REDUCTION FORCEPS WITH POINTS MEDIUM HANDLE-SOFT RATCHET

    MDR report key: 3033247 · Received April 3, 2013

    Report

    Report Number
    8030965-2013-10652
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Report Date
    April 30, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. PLACEHOLDER.

    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. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE DEVICE WAS RECEIVED FOR A MANUFACTURING EVALUATION AND ONE POINTED ARM WAS BROKEN OFF ABOVE THE HINGE. THE MICROSCOPIC VIEW OF THE BROKEN SURFACES SHOWED A HOMOGENOUS MATERIAL STRUCTURE THAT INDICATED MATERIAL CONFORMITY. THE REASON FOR THIS BREAKAGE COULD NOT BE DEFINITIVELY DETERMINED, BUT ONE POSSIBILITY IS TOO MUCH APPLIED MECHANICAL FORCE BEYOND ITS CALCULATED DESIGN. THIS COMPLAINT IS DEEMED INDETERMINATE FROM A MANUFACTURING STANDPOINT.

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 1 FOR FILE (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE, THE ARM OF THE REDUCTION FORCEPS BROKE ABOVE THE HINGE. THE BROKEN FRAGMENT WAS RETRIEVED. THE SURGEON USED ANOTHER REDUCTION FORCEPS TO COMPLETE THE PROCEDURE WITH NO FURTHER PROBLEMS. NO ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136183 REDUCTION FORCEPS WITH POINTS MEDIUM HANDLE-SOFT RATCHET HTD SYNTHES GMBH 5910076

    Patients

    Seq Age Sex Outcome Treatment
    1