BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREWDRIVER BIT AXSOS T15, AO FITTING 4.0MM LOCKING SET

    MDR report key: 4222403 · Received November 4, 2014

    Report

    Report Number
    0008031020-2014-00534
    Event Type
    Malfunction
    Date Received
    November 4, 2014
    Date of Event
    October 11, 2014
    Report Date
    October 11, 2014
    Manufacturer
    STRYKER TRAUMA SELZACH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE REPORTED EVENT THAT THE TIP OF THE SCREWDRIVER BLADE BROKE OFF COULD BE CONFIRMED. THE DEVICE HAS BEEN RECEIVED INCOMPLETE AND OBVIOUSLY DAMAGED. THE TIP WAS BROKEN AND THE FRAGMENT HAS NOT BEEN RECEIVED FOR INVESTIGATION. THE FRACTURE OCCURRED DIAGONALLY ACROSS THE TORX SHAPED TIP OF THE SCREW DRIVER BLADE AND WAS CAUSED BY EXCESSIVE FORCE, WHICH MOST LIKELY WAS APPLIED BY A POWER TOOL. BASED ON THE INVESTIGATION, THE ROOT CAUSE OF THE REPORTED BROKEN BLADE WAS ATTRIBUTED TO A USER RELATED ISSUE. A HANDLING TEST FOR T15 SCREWDRIVER AXSOS BLADE BREAKAGE STATES THAT THE TORQUE TO FAILURE OF THE TESTED BLADES, CATALOG NUMBER 702753, WAS AT LEAST 7.297NM, AND THAT SCREWDRIVER BLADES COULD NOT BE BROKEN DURING MANUAL SCREW INSERTION, AS IT IS DESCRIBED IN THE OPERATIVE TECHNIQUE. THE UNIVERSAL TORQUE LIMITING ATTACHMENT, 4NM, AO FITTING, 4.0MM LOCKING SET, CATALOG NUMBER 702750, WHICH IS LISTED IN THE OPERATIVE TECHNIQUE FOR PROXIMAL HUMERUS (LITERATURE NUMBER : 982275), LIMITS THE TORQUE TO 4NM. THE OPERATIVE TECHNIQUE CONTAINS THE FOLLOWING STATEMENT: " ADDITIONAL TIPS: [¿] 5. DO NOT USE POWER FOR FINAL INSERTION OF LOCKING SCREWS. IT IS IMPERATIVE TO ENGAGE THE SCREW HEAD INTO THE PLATE USING THE TORQUE LIMITING ATTACHMENT. ENSURE THAT THE SCREWDRIVER TIP IS FULLY SEATED IN THE SCREW HEAD, BUT DO NOT APPLY AXIAL FORCE DURING FINAL TIGHTENING. IF THE SCREW STOPS SHORT OF FINAL POSITION, BACK UP A FEW TURNS AND ADVANCE THE SCREW AGAIN (WITH TORQUE LIMITER ON). " A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. 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 ANY MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE DETERMINED DURING THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING PRIMARY SURGERY OF THE PROXIMAL HUMERUS, THE DOCTOR WAS SCREWING A 4.0 LOCKING SCREW, AND THOUGHT THE SCREWDRIVER WAS STRIPPING, BUT IT TURNED OUT THAT THE TIP OF THE SCREWDRIVER BROKE OFF. THE DOCTOR THEN USED ANOTHER ONE TO COMPLETE THE SURGERY. NO DELAY.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING PRIMARY SURGERY OF THE PROXIMAL HUMERUS, THE DOCTOR WAS SCREWING A 4.0 LOCKING SCREW, AND THOUGHT THE SCREWDRIVER WAS STRIPPING, BUT IT TURNED OUT THAT THE TIP OF THE SCREWDRIVER BROKE OFF. THE DOCTOR THEN USED ANOTHER ONE TO COMPLETE THE SURGERY. NO DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708258 SCREWDRIVER BIT AXSOS T15, AO FITTING 4.0MM LOCKING SET ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STRYKER TRAUMA SELZACH 01208Y

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other