BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANNULATED 4.0MM HEXAGONAL SCREWDRIVER

    MDR report key: 3030905 · Received April 2, 2013

    Report

    Report Number
    8030965-2013-10635
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Report Date
    September 14, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE HEXAGONAL SCREWDRIVER WAS RETURNED FOR A PRODUCT DEVELOPMENT EVALUATION AND VISUAL INSPECTION SHOWED THAT THE HEX TIP WAS BROKEN. THE FRACTURE WAS OBLIQUE TO THE AXIS OF THE SHAFT AND EXTENDED ON ONE SIDE INTO THE REGION WHERE THE TIP TRANSITIONS TO THE SHAFT. ALMOST ALL OF THE HEX TIP WAS BROKEN OFF AND WAS NOT RETURNED. OTHERWISE, THE INSTRUMENT WAS IN VERY GOOD CONDITION. THIS ISSUE HAS BEEN IDENTIFIED AND AN INTERNAL CORRECTIVE ACTION WAS OPENED TO ADDRESS THIS ISSUE. AS PART OF THE CORRECTIVE ACTION, THE MATERIAL WAS CHANGED FROM 440A STAINLESS STEEL TO 465PH STAINLESS STEEL. THE SHAFT ON THIS COMPLAINT WAS PRODUCED PRIOR TO THE IMPLEMENTED CORRECTIVE ACTION. THIS COMPLAINT IS CONSIDERED VALID FROM A DESIGN PERSPECTIVE.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP WAS BROKEN ON THE CANNULATED 4.0 MM HEXAGONAL SCREWDRIVER. ADDITIONALLY, THE HELICAL BLADE INSERTER SCREW WAS BROKEN AND DID NOT WORK CORRECTLY. THIS IS REPORT 1 OF 2 FOR THIS EVENT.

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133626 CANNULATED 4.0MM HEXAGONAL SCREWDRIVER HXX SYNTHES GMBH 4467748

    Patients

    Seq Age Sex Outcome Treatment
    1