BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MMF SCREWS,2.0X12MM, CROSS-PIN, SELF DRILLING, 4/P

    MDR report key: 8266887 · Received January 22, 2019

    Report

    Report Number
    0008010177-2019-00002
    Event Type
    Malfunction
    Date Received
    January 22, 2019
    Date of Event
    December 24, 2018
    Report Date
    June 5, 2019
    Manufacturer
    STRYKER LEIBINGER FREIBURG
    Product Code
    DZL
    UDI-DI
    34546540732027
    PMA / PMN Number
    K050535
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION RESULTS SHOW THAT THE RETURNED SCREWHEAD IS BROKEN OFF, SO THE REPORTED EVENT COULD BE CONFIRMED. THE (MEASURABLE) DIMENSIONS OF THE RETURNED SCREWHEAD ARE IN ACCORDANCE WITH THE SPECIFICATIONS. BECAUSE A FRAGMENT OF THE SCREW IS BROKEN OFF AND WAS NOT RETURNED, THE OTHER RETURNED FRAGMENT¿S CHEMICAL COMPOSITION WAS TESTED AND CONFORMS TO THE SPECIFICATION ¿ 1.4441. THE FRACTURE OF THE SCREW OCCURRED IN THE FOURTH THREAD. THE DAMAGES ON THE CROSS-PIN POINT TO HIGH TORSIONAL FORCES IN THE SCREW IN DIRECTION. THE CHANGES OF THE SURFACE¿S STRUCTURE, AS WELL AS, THE FLOW STRUCTURES IN THE THREAD AREA POINT TO EXCEEDING THE MATERIAL STRENGTH DUE TO HIGH TORSIONAL FORCES. THE FRACTURE SURFACE OF THE SCREW FRAGMENT DEMONSTRATES CONCENTRIC FLOW STRUCTURES OF A DUCTILE FORCED RUPTURE THAT WERE CAUSED BY TOO HIGH TORSIONAL FORCES DURING INSERTION. THE INVESTIGATIONS WITH THE SEM ALSO SHOW CONCENTRIC FLOW STRUCTURES (HONEYCOMB) OF A FORCED RUPTURE, WHICH ARE A RESULT OF TOO HIGH TORSIONAL FORCES DURING INSERTION OF THE SCREW. THE ORIENTATION OF THE FLOW STRUCTURES OF THE FRACTURE SURFACE, AS WELL AS, THE ORIENTATION OF THE FLOW STRUCTURES ON THE AREA OF THE THREAD SHOWS THE SCREW BROKE DURING INSERTION. NO LOT NUMBER WAS PROVIDED, AND A REVIEW OF THE SPECIFIC MANUFACTURING BATCH RECORD AND RELATED QUALITY DOCUMENTS (MANUFACTURING DOCUMENTS, INSPECTION PLAN, INSPECTION DRAWING AND RELEASE REPORT) CANNOT BE PERFORMED. THEREFORE, IT IS ALSO NOT POSSIBLE TO DETERMINE THE QUANTITY RELEASED FOR DISTRIBUTION WITHIN THE AFFECTED LOT. HOWEVER, THE INVESTIGATION STEPS CONDUCTED AND THE FURTHER PROVIDED INFORMATION DEMONSTRATE MUCH EVIDENCE THAT THE EVENT IS NOT RELATED TO A MANUFACTURING ISSUE. TO OBTAIN MORE DETAILS ABOUT THE COMPLAINED EVENT, THE SALES REP WAS CONTACTED. IT WAS FURTHER REPORTED: ¿(¿) FOR THIS CASE I KNOW NOW THAT THERE WAS NO PRE-DRILLING AND WE USED THE BLACK RATCHET SCREW DRIVER HANDLE (62-20290) ALONG WITH THE MMF BLADE (62-20135). (¿)¿. THE USED HANDLE AND BLADE ARE PART OF THE UNIVERSAL FIXATION SYSTEM MMF SELF.-DRILLING MODULE AS THE SCREW UNDER COMPLAINT. THEREFORE, THEY ARE INTENDED TO BE USED IN COMBINATION WITH THE SCREW UNDER COMPLAINT. BASED ON THE INVESTIGATION AND THE CORRESPONDING STATISTICAL EVALUATION THERE IS NO INDICATION FOR AN INCORRECTLY WORKING PRODUCT OR ANY SYSTEMATIC DESIGN, MATERIAL, OR MANUFACTURING RELATED ISSUE. THEREFORE, NO FURTHER CORRECTIVE AND/OR PREVENTIVE ACTIONS ARE DEEMED NECESSARY AT THIS TIME. THE COMPLAINT IS ADDED TO THE COMPLAINT TREND.

    Description of Event or Problem · 0

    IT WAS REPORTED BY A COMPANY REPRESENTATIVE THAT DURING A PROCEDURE THE SCREW BROKE OFF AT THE SHAFT AREA DURING INSERTION. THE BROKEN PIECE WAS REMOVED. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A DELAY.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RECEIVED AT THE MANUFACTURER FOR TESTING. AN EVALUATION WILL BE CONDUCTED UPON RECEIPT OF THE DEVICE, AND A FOLLOW-UP REPORT WILL BE SUBMITTED AFTER THE QUALITY INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A COMPANY REPRESENTATIVE THAT DURING A PROCEDURE THE SCREW BROKE OFF AT THE SHAFT AREA DURING INSERTION. THE BROKEN PIECE WAS REMOVED. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58899 MMF SCREWS,2.0X12MM, CROSS-PIN, SELF DRILLING, 4/P IMPLANT DZL STRYKER LEIBINGER FREIBURG UNKNOWN 34546540732027

    Patients

    Seq Age Sex Outcome Treatment
    1