BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.7MM COCR DYNAMIC LOCKING SCREW SLF-TPNG/28MM-STERILE

    MDR report key: 3057093 · Received April 15, 2013

    Report

    Report Number
    8030965-2013-01646
    Event Type
    Malfunction
    Date Received
    April 15, 2013
    Date of Event
    March 19, 2013
    Report Date
    March 19, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    PMA / PMN Number
    K110592
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE LOT # WAS REPORTED AS 7813307. HOWEVER, UPON REVIEW OF THE DEVICE HISTORY RECORDS, IT WAS NOTED THAT THE PART AND LOT COMBINATION DID NOT MATCH. IT IS POSSIBLE THAT THE LOT # IS 7813309. THE OUTER SCREW WAS LEFT IN SITU, THE BROKEN INNER PIN AND SCREW HEAD WERE REMOVED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. UPON REVIEW OF THE DEVICE HISTORY RECORDS IT WAS NOTED THAT THE PART/LOT NUMBER COMBINATION IS UNKNOWN. WE CAN ONLY ASSUME THAT THIS WAS THE LOT 7813309, WHICH WAS USED FOR THIS PART NUMBER. THE MANUFACTURING DOCUMENTS OF LOT 7813309 WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. ONLY THE INNER BROKEN OFF PIN IS AVAILABLE; THE BROKEN OFF PART WAS NOT RECEIVED FOR INVESTIGATION. THE RELEVANT DIAMETER OF THE INNER PIN WAS CHECKED AND FOUND TO BE ACCORDING TO THE SPECIFICATION. THE PIN BROKE AT THE THINNEST DIAMETER, WHERE IT IS EXPECTED. A MANUFACTURING CONCLUSION CANNOT BE PRESENTED DUE TO THE CONDITION AND MISSING BROKEN OFF PART OF THE PRODUCT. VISUALLY THERE DOES NOT APPEAR TO BE AN ISSUE OTHER THAN THE DAMAGE SUSTAINED BY EXTRACTION.

    Description of Event or Problem · 1

    DURING A PROCEDURE ON (B)(6) 2013, IT WAS REPORTED THE INNER PIN OF THE 3.7 MM DYNAMIC LOCKING SCREW BROKE WHEN SURGEON ATTEMPTED TO REMOVE THE SCREW. SCREW WAS BEING REMOVED BECAUSE IT WAS REQUIRING MORE THAN 1.5 NM OF TORQUE TO INSERT AND SURGEON THOUGHT THAT THE SCREW MAY HAVE DEVIATED FROM THE PRE-DRILLED TRAJECTORY. SURGEON WAS UNABLE TO REMOVE THE OUTER THREADED SLEEVE OF THE SCREW. THE OUTER SCREW WAS LEFT IN SITU, THE BROKEN INNER PIN AND SCREW HEAD WERE REMOVED. SURGEON SELECTED AN ALTERNATE PLATE HOLE AND INSERTED A NEW 3.7 MM SCREW. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS 1 OF 1 REPORT FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    160935 3.7MM COCR DYNAMIC LOCKING SCREW SLF-TPNG/28MM-STERILE HWC SYNTHES GMBH 7813307

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR