BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.3MM TI MF CORTEX SCREW SELF-TAPPING W/FLUTES 6MM

    MDR report key: 4193886 · Received October 22, 2014

    Report

    Report Number
    1719045-2014-10535
    Event Type
    Malfunction
    Date Received
    October 22, 2014
    Date of Event
    September 25, 2014
    Report Date
    September 25, 2014
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    MQN
    PMA / PMN Number
    PK981275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. DEVICE HISTORY RECORDS WAS CONDUCTED. THE REPORT INDICATES THAT THE: NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    THE RETURNED CORTEX SCREW, LOT NUMBER 7780010, WAS MANUFACTURED IN AUGUST 2014. IT WAS RECEIVED WITH THE DISTAL PORTION MISSING. THERE IS A HORIZONTAL BREAK APPROXIMATELY 1MM BELOW THE SCREW HEAD AND THE DISTAL PORTION WAS NOT RECEIVED. THERE IS WEAR TO THE CRUCIFORM RECESS AND TO THE DISTAL SIDE OF THE SCREW HEAD. THUS, THE COMPLAINT CONDITION IS CONFIRMED BUT COULD NOT BE REPLICATED SINCE THE IMPLANT WAS ALREADY BROKEN. A REVIEW OF THE CURRENT EDITION OF THE DESIGN DRAWINGS, 400_623 REVISION J, WAS PERFORMED. THE DESIGN WAS FOUND TO BE SUFFICIENT FOR ITS INTENDED USE WHEN USED AND MAINTAINED AS RECOMMENDED. THEREFORE, THIS COMPLAINT CONDITION IS NOT THE RESULT OF A DESIGN DEFICIENCY. WHEN INSERTING A SELF-TAPPING SCREW THE CORRESPONDING DRILL BIT IS TO BE USED. THE 1.0MM DRILL BITS ARE PROVIDED FOR THE 1.3MM SCREWS AND ARE COLOR CODED YELLOW FOR THE 1.3MM SYSTEM. INSERTING SCREWS WITHOUT PRE-DRILLING OR WITH AN INCORRECTLY SIZED DRILL BIT CAN RESULT IN INCREASED INSERTION TORQUE AND CAUSE SCREW FAILURE. IT IS ALSO LIKELY THAT THE BONE QUALITY IMPACTED THE COMPLAINT CONDITION. HOWEVER, BECAUSE THERE IS NOT ENOUGH INFORMATION TO DETERMINE THE EXACT CAUSE OF FAILURE FOR THE IMPLANT, THE ROOT CAUSE IS UNDETERMINED. IN CONCLUSION, THE COMPLAINT CONDITION OF A BROKEN SCREW IS CONFIRMED. THE DESIGN WAS FOUND TO BE SUFFICIENT FOR ITS INTENDED USE WHEN USED AND MAINTAINED AS RECOMMENDED. WITHOUT ADDITIONAL INFORMATION, THE ROOT CAUSE IS UNDETERMINED, HOWEVER THE COMPLAINT CONDITION IS ADEQUATELY ADDRESSED IN THE RISK ANALYSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED TIP OF SELF-DRILLING SCREW BROKE DURING INSERTION INTO CRANIAL BONE PREVENTING THE SCREW FROM BEING IMPLANTED. THIS FAILURE OCCURRED DURING A CADAVER LAB. THE SCREWS WERE INSERTED BY HAND USING THE (B)(4) SCREWDRIVER BLADE AND (B)(4) SCREWDRIVER HANDLE. NO USER OR PATIENT HARM. EXACT SCREW THAT FAILED COULD NOT BE IDENTIFIED AFTER PROCEDURE. ALL RETAINED SELF-DRILLING LPN 3MM LONG SCREWS WILL BE SENT TO COMPLAINT UNIT FOR PART NUMBER 400.833. ALSO, DURING INSERTION OF A 1.3MM SELF-TAPPING SCREW, 6MM LONG INTO A 1.0MM DIAMETER PRE-DRILLED HOLE, IN FRONTAL CRANIAL BONE, THE SCREW BROKE IN HALF NEAR THE HEAD. PLAINT UNIT FOR PART NUMBER 400.626. THE BODY OF THE SCREW WAS LEFT IN THE CADAVER SPECIMEN. THIS REPORT IS 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671171 1.3MM TI MF CORTEX SCREW SELF-TAPPING W/FLUTES 6MM MANDIBLE DISTRACTION DEVICES MQN SYNTHES MONUMENT 7780010

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR