BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANNULATED 4.0MM HEXAGONAL SCREWDRIVER

    MDR report key: 3081934 · Received April 29, 2013

    Report

    Report Number
    2530088-2013-10553
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Report Date
    December 2, 2011
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. VISUAL INSPECTION OF THE RETURNED INSTRUMENT SHOWS THAT THE HEX TIP HAS BROKEN OFF. THE BREAK IS OBLIQUE IN THAT IT IS BROKEN AT THE SHAFT TO TIP TRANSITION ON ONE SIDE AND ABOUT HALF WAY UP THE HEX TIP ON THE OPPOSITE SIDE. THE BREAK IS FAIRLY SMOOTH AS IT TRANSITIONS AROUND THE PART AND THE FRACTURE SURFACE IS HOMOGENOUS WHICH INDICATES MATERIAL UNIFORMITY. OTHERWISE, THE INSTRUMENT IS IN GOOD CONDITION. THE COMPLAINT IS VALID AND AN INTERNAL CORRECTIVE ACTION HAS BEEN OPENED TO ADDRESS THIS ISSUE.

    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

    CONSULTANT REPORTED: DURING A SCHEDULED REMOVAL PROCEDURE, THE TIP OF THE SCREWDRIVER BROKE. NOTHING BROKE INTO PATIENT, NOTHING TO RETRIEVE. THIS IS 2 OF 2 REPORTS FOR THIS EVENT, COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183370 CANNULATED 4.0MM HEXAGONAL SCREWDRIVER HXX SYNTHES BRANDYWINE A4DD007

    Patients

    Seq Age Sex Outcome Treatment
    1