BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING SCREW,T8 FULL THREAD, 2.7MM/L22MM

    MDR report key: 8784460 · Received July 12, 2019

    Report

    Report Number
    0008031020-2019-00822
    Event Type
    Malfunction
    Date Received
    July 12, 2019
    Date of Event
    May 27, 2019
    Report Date
    February 19, 2020
    Manufacturer
    STRYKER GMBH
    Product Code
    HWC
    UDI-DI
    07613327068719
    PMA / PMN Number
    K180500
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT COULD NOT BE CONFIRMED, SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER EVIDENCES WAS PROVIDED DESPITE MULTIPLE ATTEMPTS. 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 WAS NOT POSSIBLE BECAUSE THE LOT NUMBER WAS NOT COMMUNICATED. 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. H3 OTHER TEXT : DEVICE DISPOSITION UNKNOWN.

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT COULD BE CONFIRMED. THE DEVICE INSPECTION REVEALED THE FOLLOWING: THE LOCKING SECTION AND THE T8 DRIVE OF THE SCREW HEAD ARE INDEED COMPLETELY DAMAGED / DEFORMED. THE SCREW THREAD FROM THE MIDDLE TO THE TIP IS STILL IN GOOD SHAPE, ONLY SLIGHT WEAR IS VISIBLE. NOTE THAT THE LOCKING MECHANISM IS DAMAGED THAT SEVERE THAT IT IS NOT WORKING ANYMORE. BASED ON INVESTIGATION, THE ROOT CAUSE WAS ATTRIBUTED TO BE USER RELATED. THE FAILURE WAS CAUSED BY POSSIBLE INADEQUATE SCREW INSERTION / LOCKING. 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 ANY FURTHER INFORMATION IS PROVIDED, THE INVESTIGATION REPORT WILL BE UPDATED.

    Description of Event or Problem · 0

    CUSTOMER REPORTED THAT : "WHEN PERFORMING OSTEOSYNTHESIS OF THE LOWER END OF THE RIGHT RADIUS, THE LOCKED SCREW DIA 2.7 LG 22MM DID NOT LOCK INTO THE PLATE".

    Description of Event or Problem · 0

    CUSTOMER REPORTED: "WHEN PERFORMING OSTEOSYNTHESIS OF THE LOWER END OF THE RIGHT RADIUS, THE LOCKED SCREW DIA 2.7 LG 22MM DID NOT LOCK INTO THE PLATE." ADDITIONALLY REPORTED: EVENT IDENTIFIED PER-OPERATIVE. PROCEDURE COMPLETED SUCCESSFULLY. NO OTHER MEDICAL INTERVENTION. DELAY 30MIN.

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF INVESTIGATION, ADDITIONAL INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT: "WHEN PERFORMING OSTEOSYNTHESIS OF THE LOWER END OF THE RIGHT RADIUS, THE LOCKED SCREW DIA 2.7 LG 22 MM. DID NOT LOCK INTO THE PLATE.''

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580815 LOCKING SCREW,T8 FULL THREAD, 2.7MM/L22MM SCREW, FIXATION, BONE HWC STRYKER GMBH 656322 1000342206 07613327068719

    Patients

    Seq Age Sex Outcome Treatment
    1