BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANNULATED 4.0MM HEXAGONAL SCREWDRIVER

    MDR report key: 3070732 · Received April 22, 2013

    Report

    Report Number
    3003787298-2013-10082
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    December 26, 2012
    Report Date
    December 27, 2012
    Manufacturer
    SYNTHES JENNERSVILLE
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 WERE FOUND DURING MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE PRODUCT EVALUATION VISUAL INSPECTION REVEALED THAT ALMOST THE ENTIRE HEX TIP HAS BROKEN OFF JUST ABOVE THE TRANSITION TO THE SHAFT. THE BREAK IS JAGGED ON ONE CORNER BUT STRAIGHT OTHERWISE. THE BROKEN TIP WAS NOT RETURNED FOR EVALUATION. SEVERAL WEAR MARKS EXIST ON THE SHAFT WHICH ARE CONSISTENT WITH FIELD USE. 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. PRODUCT CODE HXX. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SUBTALOR FUSION, THE SURGEON WAS TIGHTENING THE SCREW AND THE SCREWDRIVER HEAD SNAPPED OFF AND THE PART WAS RETRIEVED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS A NON UNION FROM A PREVIOUS PANTALAR FUSION WITH A BIOMET ANKLE ARTHRODESIS NAIL. THE NAIL WAS LEFT IN PLACE AS THE TIBIOTALAR JOINT HAD FUSED JUST NOT SUBTALAR. NO OTHER NEW HARDWARE WAS PLACED OTHER THAN THE 7.3 SCREW WE WERE INSERTING WITH THE SCREWDRIVER IN QUESTION. IT WAS EITHER INTERDIGITATING WITH THE NAIL OR THE PATIENT HAD GOOD BONE AS THE SCREW WAS GETTING TREMENDOUS BITE, ACCORDING TO THE SURGEON. THE SCREW WAS FULLY SEATED WHEN THE DRIVER BROKE. SO IT REQUIRED NO FURTHER TIGHTENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172846 CANNULATED 4.0MM HEXAGONAL SCREWDRIVER LXH SYNTHES JENNERSVILLE A4F0653

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR