BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.0MM FLEXIBLE HEXAGONAL SCREWDRIVER

    MDR report key: 3041774 · Received April 8, 2013

    Report

    Report Number
    1719045-2013-10527
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Report Date
    March 21, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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. THE DHR WAS REVIEWED AND NO ISSUES THAT WOULD HAVE RESULTED IN THIS COMPLAINT WERE FOUND. THE DEVICE WAS RECEIVED, HOWEVER, NO EVALUATION IS AVAILABLE.

    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. THE PRODUCT DEVELOPMENT EVENT EVALUATION SHOWED ALL OF THE RETURNED PARTS HAVE PHENOLIC HANDLES WHICH IS A STANDARD INSTRUMENT HANDLE MATERIAL THAT HAS BEEN USED FOR YEARS. THE COMPLAINT NOTES THAT THERE IS BROWN RESIDUE LEACHING FROM THE HANDLES BUT THE PARTS WERE DECONTAMINATED WHEN RETURNED FROM THE FIELD AND THERE WAS NO RESIDUE ON THE PARTS WHEN THEY WERE RECEIVED FOR EVALUATION. THERE HAVE BEEN A LIMITED NUMBER OF COMPLAINTS FOR THIS CONDITION ON INSTRUMENTS WITH THE PHENOLIC (CANVESIT) MATERIAL AND THERE HAVE BEEN THOUSANDS OF INSTRUMENTS DISTRIBUTED WITH HANDLES MADE WITH THIS MATERIAL. THE FOLLOWING SHOWS THE MANUFACTURING DATES FOR THE INSTRUMENTS AND IT IS EVIDENT THAT THE RETURNED PARTS WERE ALL MANUFACTURED SEVERAL YEARS AGO AND HAVE BEEN USED WITHOUT ISSUE FOR QUITE SOME TIME. 357.406 (MANUFACTURED IN JULY 2003 AND SEPTEMBER 2004), 357.25 (MAY 2003 AND NOVEMBER 2008), 314.75 (JUNE 2003 AND SEPTEMBER 2004), 357.515 (MAY 2003 AND JANUARY 2005), 399.42 (FEBRUARY 2009), AND 399.43 (JUNE 2005). THE PARTS WERE DECONTAMINATED WHEN RETURNED FROM THE FIELD AND ANY RESIDUE THAT WAS ON THE PARTS WAS REMOVED PRIOR TO BEING RECEIVED FOR EVALUATION. SINCE THE COMPLAINT CONDITION COULD NOT BE VERIFIED OR EVALUATED, THIS COMPLAINT IS DISPOSITIONED INDETERMINATE.

    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. ORIGINAL AWARENESS DATE IS (B)(6) 2012.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 8 INSTRUMENTS ARE LEACHING A BROWN RESIDUE FROM THE HANDLES. THERE WAS A DELAY TO A PROCEDURE TO RECLEAN THE INSTRUMENTS. THE NEXT TIME THROUGH STERILE PROCESSING THE HANDLES BEGAN LEACHING AGAIN. THE CONSULTANT REPLACED ALL PARTS THROUGH A POR, AS THEY WERE NEEDED FOR UPCOMING CASES. INSTRUMENTS WERE REPORTEDLY OLD AND NEEDED REPLACING. THIS IS 2 OF 10 REPORTS FOR THIS EVENT.

    Description of Event or Problem · 1

    THIS IS REPORT 2 OF 10 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143672 5.0MM FLEXIBLE HEXAGONAL SCREWDRIVER HXX SYNTHES MONUMENT 54696

    Patients

    Seq Age Sex Outcome Treatment
    1