BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING SCREW, FULLY THREADED T2 TIBIA 5X40 MM

    MDR report key: 11237993 · Received January 27, 2021

    Report

    Report Number
    0009610622-2021-00252
    Event Type
    Malfunction
    Date Received
    January 27, 2021
    Date of Event
    January 12, 2021
    Report Date
    March 19, 2021
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    HSB
    UDI-DI
    04546540202499
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: REFER TO H3 (REASON CODE); H6 CONCLUSION CODE. THE REPORTED EVENT COULD NOT BE CONFIRMED, SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER EVIDENCES WERE PROVIDED. THE DEVICE INSPECTION WAS NOT POSSIBLE AS THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. MORE DETAILED INFORMATION ABOUT THE COMPLAINT EVENT AS WELL AS THE AFFECTED DEVICE MUST BE AVAILABLE IN ORDER TO DETERMINE THE ROOT CAUSE OF THE COMPLAINT EVENT. HOWEVER, BASED ON THE RECEIVED INFORMATION IT¿S CLEAR THAT LOCKING SCREW WAS INSERTED PRIOR TO THE SCN NAIL TO GUIDE THE NAIL AS A BLOCKING TECHNIQUE WHICH IS NOT SPECIFIED IN THE RESPECTIVE OPERATIVE TECHNIQUE OF SCN NAILING SYSTEM. HENCE, IT CAN BE CONCLUDED THAT THE EVENT IS USER RELATED (OFF LABEL USE). IF DEVICE IS RETURNED OR ANY FURTHER INFORMATION IS PROVIDED, THE INVESTIGATION REPORT WILL BE REASSESSED. H3 OTHER TEXT : DEVICE IS NOT AVAILABLE; DISPOSED BY HOSPITAL.

    Description of Event or Problem · 0

    AS REPORTED: "SURGEON INSERTED A 5.0 LOCKING SCREW ACTING AS A "BLOCKING SCREW." WHILE INSERTING THE SCN (SUPRACONDYLAR NAILING SYSTEM), THE NAIL BROKE THE BLOCKING SCREW IN HALF. THE SURGEON WAS ABLE TO REMOVE THE TOP HALF OF THE SCREW, BUT THE BOTTOM HALF WAS LEFT IN THE PATIENT PERMANENTLY. THE SCN WAS IMPLANTED AND THE REST OF THE CASE WAS COMPLETED SUCCESSFULLY."

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. DEVICE REMAINS IN THE PATIENT.

    Description of Event or Problem · 1

    AS REPORTED: "SURGEON INSERTED A 5.0 LOCKING SCREW ACTING AS A "BLOCKING SCREW." WHILE INSERTING THE SCN (SUPRACONDYLAR NAILING SYSTEM), THE NAIL BROKE THE BLOCKING SCREW IN HALF. THE SURGEON WAS ABLE TO REMOVE THE TOP HALF OF THE SCREW, BUT THE BOTTOM HALF WAS LEFT IN THE PATIENT PERMANENTLY. THE SCN WAS IMPLANTED AND THE REST OF THE CASE WAS COMPLETED SUCCESSFULLY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135858 LOCKING SCREW, FULLY THREADED T2 TIBIA 5X40 MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB STRYKER TRAUMA KIEL 1896-5040S K03BB0D 04546540202499

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR