BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMBINATION T-WRENCH 8MM

    MDR report key: 3072088 · Received April 23, 2013

    Report

    Report Number
    1719045-2013-10746
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    October 11, 2011
    Report Date
    October 11, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HXC
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    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. MANUFACTURING EVALUATION REPORTS THAT THE COMBINATION WRENCH WAS RETURNED WITH THE END BROKEN PARTIALLY OFF. TWO FACES OF THE HEX FEATURE REMAINS AT THE TIP. THE MEASURABLE DIMENSIONS ARE WITHIN PRINT SPECIFICATION. DUE TO MISSING PORTIONS VERIFICATION OF PHYSICAL DIMENSIONS COULD NOT BE COMPLETED. THIS COMPLAINT IS INDETERMINATE FROM A MANUFACTURING STANDPOINT.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE OR UNCHANGED. RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. A REVIEW OF THE DHR INDICATES THERE WERE NO ANOMALIES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THIS COMPLAINT. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE SUPPLIERS CERTIFICATIONS INDICATE THE CORRECT MATERIAL WAS USED AND CORRECT HARDNESS VALUES WERE OBTAINED. ALL RECORDS INDICATE THE PRODUCT WAS MANUFACTURED TO SPECIFICATIONS. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FRONT END OF THE COMBINATION T-WRENCH BROKE WHILE TRYING TO REMOVE THE ROD ATTACHMENT FROM THE MEDIUM PIN CLAMP. THE DEVICE IS BRAND NEW AND HAS NOT BEEN USED IN A PROCEDURE.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173852 COMBINATION T-WRENCH 8MM HXC SYNTHES MONUMENT 6553860

    Patients

    Seq Age Sex Outcome Treatment
    1