BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREWDRIVER BIT AXSOS T15, AO FITTING 4.0MM LOCKING SET

    MDR report key: 10840336 · Received November 13, 2020

    Report

    Report Number
    0008031020-2020-02449
    Event Type
    Malfunction
    Date Received
    November 13, 2020
    Date of Event
    October 21, 2020
    Report Date
    January 13, 2021
    Manufacturer
    STRYKER GMBH
    Product Code
    LXH
    UDI-DI
    07613327005028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT COULD BE CONFIRMED, SINCE THE PRODUCT WAS RETURNED FOR EVALUATION AND MATCHES THE ALLEGED FAILURE MODE. THE DEVICE INSPECTION REVEALED THE FOLLOWING: THE SCREWDRIVER BIT TIP FOUND TO BE BROKEN. THE BREAKAGE SURFACE SHOWS SIGNS OF ROTATIONAL DEFORMATION/WAVES. ABSENCE OF PLASTIC DEFORMATION INDICATES THAT THE BREAKAGE WAS INSTANTANEOUS DUE TO HIGH TORSIONAL AND BENDING OVERLOAD. HOWEVER, IT CANNOT BE EXCLUDED THAT RESIDUAL STRESS FROM PREVIOUS USAGE ALSO CONTRIBUTED IN THE BREAKAGE. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. THE ABOVE INVESTIGATION HAS DETERMINED THE FAILURE MODE RELATED TO THIS COMPLAINT IS BEING ADDRESSED BY THE SCOPE OF NC # 1143497. THIS WAS OPENED IN ORDER TO ADDRESS THE RECURRING SITUATION OF THE BREAKAGES OF THE TIPS FOR THE ¿SCREWDRIVER BIT AXSOS T15 AO FITTING 4.0MM LOCKING SET¿ WITH CAT # 702753, AND WAS ALSO EXTENDED TO CATALOGS # 702754, 702747 AND 702748. ACCORDING TO THIS NC, IT WAS CONCLUDED THAT "THE INVESTIGATION OF THE COMPLAINT SITUATION AND OF THE MECHANICAL STRENGTH OF THE SCREWDRIVER HAS SHOWN THAT THE DESIGN OPTIMIZATION PERFORMED IN 2011 (CAPA # 13449) WAS EFFECTIVE AND THAT A FURTHER INCREASE OF THE SCREWDRIVER TORQUE TO FAILURE IS NOT POSSIBLE, AS THIS WOULD LEAD TO SCREW DAMAGE IN CASE OF OVER TIGHTENING.¿ AS A RESULT, CAPA # 13449 WAS OPENED. THIS CAPA WAS OPENED, AS AN OPPORTUNITY TO IMPROVE THE DESIGN OF THE SCREWDRIVER BLADES. DESIGN CHANGE SEL 11-321 WAS IMPLEMENTED TO ADDRESS THESE BREAKAGES: THE BLADE OF THE SCREWDRIVER WAS SHORTENED IN ORDER TO INCREASE ITS STRENGTH AND CONSEQUENTLY REDUCE THE AMOUNT OF BREAKAGES. BASED ON THE ABOVE INVESTIGATION, THE ROOT CAUSE OF THE FAILURE IS USER RELATED. THE BREAKAGE OF THE TIP HAPPENED DUE TO A TORSIONAL AND BENDING OVERLOAD, THE LIKELIHOOD OF WHICH IS GREATER DURING AN EXPLANTATION. IF ANY FURTHER INFORMATION IS PROVIDED, THE COMPLAINT REPORT WILL BE UPDATED.

    Description of Event or Problem · 0

    AS REPORTED: "TIBIAL PROXIMAL ORIF. REMOVED AXSOS PT. THE SCREW ON THE JOINT SURFACE DID NOT COME OFF, AND TWO SCREWDRIVER TIPS BROKE. AFTER CUTTING THE TIP OF THE SCREW WITH A CARBIDE, I SCRAPED THE CIRCUMFERENCE A LITTLE LARGER AND MANAGED TO REMOVE IT."

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    AS REPORTED: "TIBIAL PROXIMAL ORIF. REMOVED AXSOS PT. THE SCREW ON THE JOINT SURFACE DID NOT COME OFF, AND TWO SCREWDRIVER TIPS BROKE. AFTER CUTTING THE TIP OF THE SCREW WITH A CARBIDE, I SCRAPED THE CIRCUMFERENCE A LITTLE LARGER AND MANAGED TO REMOVE IT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1303141 SCREWDRIVER BIT AXSOS T15, AO FITTING 4.0MM LOCKING SET ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STRYKER GMBH 702753 J02745 07613327005028

    Patients

    Seq Age Sex Outcome Treatment
    1