BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI LOW PROFILE NEURO SCREW SELF-DRILLING 3MM

    MDR report key: 3061833 · Received April 16, 2013

    Report

    Report Number
    1719045-2013-10600
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    June 3, 2012
    Report Date
    June 6, 2012
    Manufacturer
    SYNTHES (USA)
    Product Code
    DZL
    PMA / PMN Number
    K031807
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    Reporter Occupation
    RISK MANAGER

    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. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE MANUFACTURING EVALUATION, VISUAL INSPECTION REPORT STATES THE POINT ON THE TIP OF THE SCREW IS DULL WHICH IS CONSISTENT WITH THE COMPLAINT. THE REST OF THE SCREW IS IN FAIR CONDITION. SINCE THE SCREW TIP COULD NOT BE INSPECTED DUE TO DAMAGE AND NO LOT NUMBER WAS PROVIDED THIS COMPLAINT IS INDETERMINATE FROM A MANUFACTURING STANDPOINT.

    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. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4). (B)(4).

    Additional Manufacturer Narrative · 1

    DATE OF EVENT (B)(6) 2012.

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE SURGEON PERFORMING A CRANIOTOMY ON THE PATIENT, TWO LOW-PROFILE NEURO SCREWS BROKE DURING INSERTION. ALL FRAGMENTS WERE RETRIEVED AND ARE AVAILABLE TO RETURN. THE SYNTHES CONSULTANT WAS NOT PRESENT DURING THE SURGERY, BUT LATER WAS NOTIFIED BY HOSPITAL THAT THE PATIENT HAD DIED. UPDATE (B)(6) 2012: PER THE HOSPITAL, NO PATIENT DETAILS WILL BE PROVIDED. THE PATIENT SUFFERED MAJOR HEAD TRAUMA AND HAD SURGICAL REPAIR, AT THE END OF THE PROCEDURE THE SURGEON WAS INSERTING SCREWS WHEN TIPS BROKE OFF. THE SURGEON REMOVED THE SCREWS AND REPLACED THEM WITH NEW SCREWS, NO INCIDENT OR IMPACT TO PATIENT WAS REPORTED AND THE PROCEDURE WAS COMPLETED. THE PATIENT EXPIRED 24 TO 48 HOURS POST-OP DUE TO MULTIPLE CARDIAC ARRESTS AND INTERCRANIAL HEMORRHAGE DUE TO INITIAL MAJOR HEAD TRAUMA. PER THE FACILITY RISK MANAGER, ALONG WITH THE SYNTHES POST MARKET RISK MANAGER, SYNTHES DEVICES HAD NO IMPACT ON THIS EVENT. EVENT #1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163557 TI LOW PROFILE NEURO SCREW SELF-DRILLING 3MM DZL SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1