BEUDAMED
    FDA Adverse Event Other Summary report: N

    DRILL

    MDR report key: 17333136 · Received July 14, 2023

    Report

    Report Number
    MW5119449
    Event Type
    Other
    Date Received
    July 14, 2023
    Date of Event
    July 11, 2023
    Report Date
    July 13, 2023
    Manufacturer
    STRYKER INSTRUMENTS
    Product Code
    HWE
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    EVENT DESCRIPTION: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2023, WHILE ATTEMPTING TO PUT IN A LOCKING SCREW, THE TORQUE LIMITER WOULD NOT CONNECT TO THE STRYKER DRILL ATTACHMENT FOR THE SURGEON TO INSERT ON POWER. IT IS UNKNOWN IF THE STRYKER QUICK CONNECT WAS NOT WORKING PROPERLY, OR IF THE TORQUE LIMITER HAD ISSUES. ADDITIONALLY, THE SURGICAL TECH NOTICED THAT THE TIP OF A T-25 SCREWDRIVER WAS ROUNDED OFF AND RISKING STRIPPING THE HEADS OF THE SCREWS BECAUSE IT DID NOT SEAT PROPERLY. THE SCREWS WERE HAND TIGHTENED AT THE END OF THE CASE. THE SPD MANAGER WAS ADVISED TO REPLACE THESE PRODUCTS FROM THE SETS. PROCEDURE WAS COMPLETED WITH NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1715982 DRILL INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT HWE STRYKER INSTRUMENTS

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown T-25 SCREWDRIVER.| TORQUE LIMITER.