BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6.0MM TI MATRIX SCREW 45MM THREAD LENGTH

    MDR report key: 3092626 · Received May 3, 2013

    Report

    Report Number
    2520274-2013-02333
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 8, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    NKB
    PMA / PMN Number
    K100952
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. SCREW RECEIVED IN PRISTINE CONDITION, WITH EXCEPTION OF FULL FIRST THREAD OF INSTRUMENT BEING BROKEN OFF IN THE M6.5 X 0.75-6H THREAD. ALL DESCRIBED NONCONFORMITIES ARE POST MANUFACTURING. THERE IS NO COMPLAINT AGAINST THIS SCREW; COMPLAINT IS THAT THE INSTRUMENT BROKE INTO HEAD OF SCREW. THE M6.5 X 0.75-6H THREAD CANNOT BE MEASURED BECAUSE OF BROKEN INSTRUMENT. THE INSTRUMENT DID THREAD ONE FULL REVOLUTION INTO SCREW AS DESIGNED.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: THE PRODUCT DEVELOPMENT EVENT EVALUATION FOR PART 03.632.001 STATES THAT IT¿S A HOLDING SLEEVE FOR THE MATRIX PEDICLE SCREW SYSTEM. IMPROPER USE OF THIS HOLDING SLEEVE CAN CONTRIBUTE TO THE HAZARD EXPERIENCED IN THIS COMPLAINT. THE TECHNIQUE GUIDE ILLUSTRATES HOW TO PROPERLY LOAD AND TIGHTEN THE HOLDING SLEEVE INTO THE RECESS OF THE SCREW AND CAUTIONS NOT TO GRASP THE GREEN KNOB DURING SCREW INSERTION AS THIS WILL CAUSE THE HOLDING SLEEVE TO DISENGAGE FROM THE SCREW. THE LOT# FOR THIS COMPLAINT IS (B)(4). SYNTHES RECEIVED THIS LOT ON 10/4/10. THIS DATE IS PRIOR TO THE CHANGES IMPLEMENTED AS A RESULT OF CAPA (B)(4). REFERENCED FROM CW # (B)(4): "MECHANICAL TESTING OF THIS INSTRUMENT HAS SHOWN THAT WHEN INSTALLED PROPERLY THE TORSIONAL STRENGTH OF THE THREADS ARE IN EXCESS OF 10NM. IT WOULD BE EXTREMELY DIFFICULT TO APPLY A TORQUE OF THAT MAGNITUDE TO THE SMALL KNOB PROVIDED TO TIGHTEN THIS INSTRUMENT. BASED ON THE THREADS BELOW THE FRACTURE POINT ON THE RETURNED INSTRUMENT IT APPEARS THAT THE INSTRUMENT WAS CROSS THREADED TO THE BONE SCREW AND WEAKENED TO THE TIP OF THE INSTRUMENT." THE TECHNIQUE GUIDE ILLUSTRATES HOW TO PROPERLY LOAD AND TIGHTEN THE HOLDING SLEEVE INTO THE RECESS OF THE SCREW AND CAUTIONS NOT TO GRASP THE GREEN KNOB DURING SCREW INSERTION AS THIS WILL CAUSE THE HOLDING SLEEVE TO DISENGAGE FROM THE SCREW. BASED ON THE U.S. SALES OF THE LIFE OF THE PRODUCT ((B)(4)), THE OCCURRENCE RATE OF THE HOLDING SLEEVE CROSS-THREADING/BREAKING DURING SCREW LOADING IS APPROXIMATELY (B)(4). (B)(4). THIS COMPLAINT IS ALSO BEING EVALUATED UNDER CAPA (B)(4), THE CAPA DETERMINATION WAS COMPLETED AND NO FURTHER CORRECTIVE ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. ENTERED IN ERROR, IS A SINGLE USE DEVICE.

    Description of Event or Problem · 1

    DURING A PLF PROCEDURE AT LEVELS L4-S1, THE SCRUB TECH WAS LOADING THE SCREW ONTO THE SCREWDRIVER. THE THREADS OF THE DRIVER BROKE INTO THE HEAD OF THE SCREW. THE DRIVER WAS SWAPPED OUT FOR A NEW ONE. THERE WAS NO HARM TO THE PATIENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193946 6.0MM TI MATRIX SCREW 45MM THREAD LENGTH NKB SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR