BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CALCLOCK

    MDR report key: 867498 · Received March 16, 2007

    Report

    Report Number
    3005039508-2007-00001
    Event Type
    Malfunction
    Date Received
    March 16, 2007
    Date of Event
    February 19, 2007
    Report Date
    February 19, 2007
    Manufacturer
    ORTHOHELIX SURGICAL DESIGNS, INC.
    Product Code
    HWC
    PMA / PMN Number
    K061400
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INTENDED USE FOR THIS SLOT / SCREW INTERFACE WAS TO INSERT THE SCREW PERPENDICULARLY TO THE PLATE AND BEFORE SYNCHING THE PLATE DOWN, TO HAVE THE OPTION TO TRANSLATE THE PLATE IN THE ANTERIOR-POSTERIOR PLANE. THE SURGICAL TECHNIQUE (CAT-800-001) HAS BEEN UPDATED TO REVISION LEVEL 1 TO CLEARLY DEPICT THE INTENDED USAGE WITH RESPECT TO THE ANGULATION OF THE SCREW IN THE SLOT (STEP 8) AND HAS BEEN DISTRIBUTED. THIS CHANGE FURTHER SPECIFIED THE INTENDED USAGE WITH RESPECT TO EMPHASIZING THE METHOD OF SEATING THE SCREWS: IMPLEMENTING THE TWO FINGER FINISHING TECHNIQUE (STEP 10).

    Description of Event or Problem · 1

    DURING FRACTURE REPAIR SURGERY, A SCREW PASSED THROUGH A SLOT IN THE PLATE. THE SURGEON STATED THAT HE INSERTED THE SCREW AT AN EXTREME ANGLE AND APPLIED HEAVY AMOUNT OF FINISHING TORQUE. THERE WAS NO REPORTED INJURY OR HARM TO THE PT. THE SCREW WAS LEFT IN THE PT AND ESSENTIALLY USED AS AN INTER-FRAGMENTARY SCREW, WHICH IS COMMONPLACE IN CALCANEUS RECONSTRUCTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CALCLOCK FRACTURE REPAIR PLATE AND SCREW HWC ORTHOHELIX SURGICAL DESIGNS, INC. * L217

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR