BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANNULATED CRUCIFORM SCREWDRIVER

    MDR report key: 3011359 · Received March 19, 2013

    Report

    Report Number
    2530088-2013-10265
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Date of Event
    February 16, 2012
    Report Date
    February 16, 2012
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    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 PRODUCT DEVELOPMENT EVALUATION REVEALED THAT ALL FOUR CRUCIFORM TIPS ARE BROKEN OFF AT THE BASE WHERE THE TIP TRANSITIONS TO THE SHAFT. ALL THE FRACTURE FACES ARE SMOOTH AND THERE ARE NO INDICATIONS OF ANY MATERIAL ANOMALIES. THE RETURNED DEVICE WAS MANUFACTURED IN FEBRUARY 1999 AND IS OVER 13 YEARS OLD. THERE HAVE ONLY BEEN THREE OTHER COMPLAINTS IN THE 2 YEAR HISTORY FOR THIS ISSUE, THIS SCREWDRIVER WAS REPLACED BY THE 314.463 IN 2000, THERE HAVE BEEN NONE DISTRIBUTED IN THE LAST TWO YEARS. THE RETURNED DEVICE HAS ALL FOUR TINES BROKEN OFF AT THE TRANSITION OF THE TIP TO THE SHAFT AND THE FRAGMENTS WERE NOT RETURNED. THE FRACTURE SURFACES ON THE TIP ARE UNIFORM AND THERE IS NO INDICATION OF ANY MATERIAL ANOMALIES. THE SHAFT IS MADE FROM (B)(4) AND IS A STANDARD MATERIAL FOR AN INSTRUMENT OF THIS TYPE. THE COMPLAINT CONDITION IS MOST LIKELY THE RESULT OF THE DEVICE BEING SUBJECTED TO EXCESSIVE TORQUE. BASED ON THE AGE AND CONDITION OF THE DEVICE, IT APPEARS THAT THE DEVICE WAS SUBJECTED TO EXCESSIVE TORQUE. THE DESIGN IS ADEQUATE FOR THE INTENDED USE AND THEREFORE IT IS CONCLUDED THAT THIS COMPLAINT IS INVALID. PLACEHOLDER.

    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. 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.(B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ORIF OF A FINGER, THE TIP OF A CANNULATED CRUCIFORM SCREWDRIVER BROKE OFF. SURGEON RETRIEVED THE BROKEN TIP AND THE PATIENT WAS NOT HARMED. INSTRUMENT IS AVAILABLE FOR RETURN.

    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
    113270 CANNULATED CRUCIFORM SCREWDRIVER HXX SYNTHES BRANDYWINE A4JE621

    Patients

    Seq Age Sex Outcome Treatment
    1