BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI MATRIXMIDFACE SCREW SELF-DRILLING 8MM

    MDR report key: 3072627 · Received April 23, 2013

    Report

    Report Number
    1719045-2013-10720
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Report Date
    September 27, 2011
    Manufacturer
    SYNTHES USA
    Product Code
    JEY
    PMA / PMN Number
    K083388
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, 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. MANUFACTURING EVALUATION REPORTS THE PART WAS RECEIVED BROKEN AT THE SHAFT JUST BELOW THE HEAD. THE REMAINING THREADS ARE DAMAGED AND THE SHAFT IS BENT. DUE TO DAMAGES, INSPECTION OF RELEVANT FEATURES COULD NOT BE COMPLETED. THEREFORE THIS COMPLAINT IS INDETERMINATE FROM A MANUFACTURING STANDPOINT. THE LOT NUMBER IS UNKNOWN THEREFORE A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE COMPLETED.

    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.(B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) PROCEDURE FOR A MIDFACE FRACTURE, THE HEAD OF A SCREW POPPED OFF WHEN THE SURGEON ATTEMPTED INSERTION. THE SCREW HEAD WAS RETRIEVED AND THE SHAFT WAS LEFT IN THE PATIENT. THE PATIENT HAD VERY HARD CORTICAL BONE AND THE SURGEON DECIDED TO PRE-DRILL THE REST OF THE HOLES BEFORE INSERTING THE SCREWS. THE SURGEON WAS ABLE TO COMPLETE THE PROCEDURE WITH NO ADVERSE EFFECT TO THE PATIENT.

    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
    174224 TI MATRIXMIDFACE SCREW SELF-DRILLING 8MM JEY SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1