BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONE SCREW, T8 FULL THREAD, 2.7MM/L16MM

    MDR report key: 8824840 · Received July 24, 2019

    Report

    Report Number
    0008031020-2019-00925
    Event Type
    Malfunction
    Date Received
    July 24, 2019
    Date of Event
    July 3, 2019
    Report Date
    September 10, 2019
    Manufacturer
    STRYKER GMBH
    Product Code
    HWC
    UDI-DI
    07613327070880
    PMA / PMN Number
    K180500
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT COULD NOT BE CONFIRMED, SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER EVIDENCE WAS PROVIDED. NOTE THAT THE BROKEN SCREW HEAD HAD BEEN DISPOSED BY THE HOSPITAL, IT WAS DECIDED BY THE SURGEON TO LEAVE THE SCREW CORE IN SITU. 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. 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. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. IF THE DEVICE IS RETURNED OR IF ANY ADDITIONAL INFORMATION IS PROVIDED, THE INVESTIGATION WILL BE REASSESSED.

    Description of Event or Problem · 0

    CUSTOMER REPORTED THAT THE SURGEON WAS PLACING THE SCREW IN ON HAND INTO A PATIENT, WHEN THE SCREW HEAD CAME AWAY FROM THE SCREW ITSELF AS HE MADE THE FINAL FEW TURNS. BONE QUALITY WAS GOOD. THE SCREW HEAD DID NOT FALL INTO THE PATIENT. FINAL TIGHTENING WAS MADE BY HAND.

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. BROKEN PIECE WAS DISCARDED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE SURGEON WAS PLACING THE SCREW IN ON HAND INTO A PATIENT, WHEN THE SCREW HEAD CAME AWAY FROM THE SCREW ITSELF AS HE MADE THE FINAL FEW TURNS. BONE QUALITY WAS GOOD. THE SCREW HEAD DID NOT FALL INTO THE PATIENT. FINAL TIGHTENING WAS MADE BY HAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618470 BONE SCREW, T8 FULL THREAD, 2.7MM/L16MM SCREW, FIXATION, BONE HWC STRYKER GMBH 1000355742 07613327070880

    Patients

    Seq Age Sex Outcome Treatment
    1