BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TORQUE LIMITING ATTACHMENT 1.5NM/QUICK COUPLING

    MDR report key: 3894762 · Received June 25, 2014

    Report

    Report Number
    2520274-2014-12158
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Report Date
    May 30, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    GEY
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED IN VETERINARY CASE. NO PATIENT INFORMATION WILL BE REPORTED. DATE IF EVENT: UNKNOWN; IT WAS NOTED THAT 14 DAYS POST-OPERATIVELY THE SCREWS WERE NOT LOOSE. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DEVICE WAS 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

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THIS REPORT IS FOR A VETERINARY CASE; THERE WAS NO HUMAN PATIENT INVOLVEMENT. IT WAS REPORTED THAT POSTOPERATIVELY FOUR SCREWS LOOSENED. IT WAS REPORTED THAT THREE SCREWS WERE PROXIMAL SCREWS; THERE WERE THREE LOCKING SCREWS AND ONE CORTEX SCREW. THE LOCKING SCREWS HAD BEEN SECURED WITH THE TORQUE LIMITING ATTACHMENT WITHOUT ADDITIONAL HAND TIGHTENING. THERE WAS NO REVISION SURGERY. THE PATIENT¿S STATUS WAS REPORTED AS SUCCESSFUL; THERE WAS NO MORE LAMENESS, NO PAIN AT HIP MOBILIZATION, AND PERFECT HIP STABILITY AS TESTED WITH AN ALDO DEVICE. THIS IS REPORT 3 OF 3 FOR COM-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370422 TORQUE LIMITING ATTACHMENT 1.5NM/QUICK COUPLING MOTOR, SURGICAL INSTRUMENT, AC-POWERED GEY SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1