BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING SCREWS, SELF DRILLING, 2.0X8MM, 5/P

    MDR report key: 7842261 · Received September 4, 2018

    Report

    Report Number
    0008010177-2018-00084
    Event Type
    Malfunction
    Date Received
    September 4, 2018
    Date of Event
    August 8, 2018
    Report Date
    March 19, 2019
    Manufacturer
    STRYKER LEIBINGER FREIBURG
    Product Code
    DZL
    UDI-DI
    34546540732058
    PMA / PMN Number
    K122313
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR INVESTIGATION. ADDITIONAL INFORMATION REGARDING THE EVENT HAS BEEN REQUESTED. THE SALES REPRESENTATIVE HAS PROVIDED THE FOLLOWING DETAILS; THE SURGEON HAD USED THE 2.0/2.3 MM UNIVERSAL SCREWDRIVER BLADE (62-20130), ALONG WITH THE UNIVERSAL SCREWDRIVER HANDLE, RATCHET (62-20290) DURING SURGERY. THE DEVICES INCLUDING THE BROKEN SCREW ARE PART OF THE HYBRID MMF MODULE. IMPLANTS AND INSTRUMENTS ARE PRODUCED AND DESIGNED TO BE USED TOGETHER. THE SALES REPRESENTATIVE HAS MENTIONED THAT, THE BREAKAGE OCCURRED WHEN THE SCREW WAS INSERTED 6-7MM IN THE BONE AND THAT THE THREAD OF THE SCREW WAS LEFT IN PATIENT. THE FOLLOWING ARE EXAMPLES OF POSSIBLE ROOT CAUSES ACCORDING TO THE RELATED RISK MANAGEMENT FILE: WRONG PILOT HOLE - SCREW INTERFACE DUE TO WRONG HOLE DIAMETER/ TAPPED HOLE. IMPROPER IMPLANT PLACEMENT (E.G. ARCH BAR, SCREW...). TOO MUCH/ WRONG FORCES BETWEEN BLADE, SCREW AND BONE (E.G. SCREW HEAD DEFORMATION, SCREW BREAKAGE). TOO MUCH/ WRONG COMPRESSION/ TORSIONAL/ AXIAL FORCES. THIS IS CONFIRMED BY PREVIOUS INVESTIGATIONS ((B)(4)) WHERE IT WAS DETERMINED THAT INTRAOPERATIVE SCREW BREAKAGES WERE THE RESULT OF TOO HIGH TORSIONAL FORCES IN FORCED RUPTURE MODE DURING INSERTION. PRODUCT WAS NOT RETURNED TO EVALUATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SURGEON WAS DOING A MANDIBLE FX AND WAS INSERTING THE HYBRID MMF SCREW AND THE SCREW BROKE. A HANDHELD SCREWDRIVER WAS USED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AFTER USING ANOTHER SCREW. NO SIGNIFICANT DELAY AND NO ADVERSE CONSEQUENCE WAS REPORTED.

    Additional Manufacturer Narrative · 1

    DEVICE IS NOT AVAILABLE FOR EVALUATION. IF ADDITIONAL INFORMATION IS RECEIVED IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT. DEVICE UNABLE TO BE RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON WAS DOING A MANDIBLE FX AND WAS INSERTING THE HYBRID MMF SCREW AND THE SCREW BROKE. A HANDHELD SCREWDRIVER WAS USED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AFTER USING ANOTHER SCREW. NO SIGNIFICANT DELAY AND NO ADVERSE CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683939 LOCKING SCREWS, SELF DRILLING, 2.0X8MM, 5/P IMPLANT DZL STRYKER LEIBINGER FREIBURG UNKNOWN 34546540732058

    Patients

    Seq Age Sex Outcome Treatment
    1