BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANNULATED CRUCIFORM SCREWDRIVER

    MDR report key: 3070627 · Received April 22, 2013

    Report

    Report Number
    2530088-2013-10456
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    June 14, 2012
    Report Date
    June 14, 2012
    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. ORIGINAL AWARENESS DATE IS (B)(4) 2012. PLACEHOLDER.

    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 DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES. PRODUCT DEVELOPMENT EVALUATION STATED THAT ONE OF THE CRUCIFORM TIPS IS BROKEN OFF NEAR THE BASE OF THE TIPS WHERE IT TRANSITIONS TO THE SHAFT. THE BROKEN TIP WAS RETURNED. THE TWO ADJACENT TIPS ARE SLIGHTLY BENT IN THE DIRECTION OF TIGHTENING A SCREW AND THE OPPOSITE TIP IS STRAIGHT AND DOES NOT APPEAR TO BE BENT OR OFF-AXIS. THE FRACTURE SURFACES ON THE FRAGMENT AND TIP ARE UNIFORM AND THERE IS NO INDICATION OF ANY MATERIAL ANOMALIES. BASED ON THE BENDING OBSERVED ON THE ADJACENT TIPS AND NONE ON THE OPPOSING TIP, IT APPEARS THAT THE SCREWDRIVER WAS USED OFF-AXIS AND SUBJECTED TO EXCESSIVE TORQUE WHICH RESULTED IN THE BREAKAGE. THE RETURNED DEVICE WAS MANUFACTURED IN OCTOBER 1997 AND IS OVER 14 YEARS OLD. BASED ON THE AGE AND CONDITION OF THE DEVICE, IT APPEARS THAT THE DEVICE WAS USED OFF-AXIS AND SUBJECTED TO EXCESSIVE TORQUE. THE DESIGN IS ADEQUATE FOR THE INTENDED USE AND THEREFORE THIS COMPLAINT IS INVALID.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS FOR TREATMENT, NOT DIAGNOSIS.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING AN ANKLE CANNULATED SCREW PROCEDURE, TIP OF SCREWDRIVER BROKE WHILE INSERTING A SCREW. PIECE WAS RETRIEVED, NO HARM TO PATIENT. THIS IS 1 OF 1 REPORT FOR EVENT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171693 CANNULATED CRUCIFORM SCREWDRIVER HXX SYNTHES BRANDYWINE A4GN870

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR