BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MISC ORTHO SURGICAL INSTR

    MDR report key: 3864094 · Received June 10, 2014

    Report

    Report Number
    2520274-2014-11715
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    April 10, 2014
    Report Date
    April 11, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    KWQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT FOR DIAGNOSIS. THIS REPORT IS FOR 1 UNKNOWN PART AND UNKNOWN LOT NUMBER. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO LOT NUMBER, PART NUMBER OR PRODUCT WAS PROVIDED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR ONE (1) UNKNOWN TORQUE LIMITER.DEVICE USED FOR TREATMENT, NOT DIAGNOSIS.IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    THIS REPORT IS FOR ONE (1) UNKNOWN TORQUE LIMITER.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE, REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE DEVICES WERE USED FOR A DISTAL RADIUS FRACTURE CASE. THE SCREW WAS INSERTED INTO THE ANGLED SCREW HOLE TOWARD THE RADIAL STYLOID PROCESS AT THE MOST DISTAL RADIAL SIDE USING THE TORQUE LIMITER. THE SURGEON FOUND THAT THE TORQUE LIMITER WAS SPINNING AND THE SCREW COULD NOT BE LOCKED. HE DIDN¿T HEAR A CLICKING SOUND OF THE TORQUE LIMITER, SO HE USED A SHORTER SCREW AS A SUBSTITUTE AND FINISHED THE OPERATION. DUE TO THE INCIDENT, THE OPERATION WAS EXTENDED FOR 15 MINUTES, THERE WAS NO PATIENT HARM. THIS REPORT IS 3 OF 3 FOR AN UNKNOWN TORQUE LIMITER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337688 MISC ORTHO SURGICAL INSTR KWQ SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1