BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TORQ STERNAL CLOSURE DEVICE

    MDR report key: 2759811 · Received September 10, 2012

    Report

    Report Number
    3007603855-2012-00001
    Event Type
    Malfunction
    Date Received
    September 10, 2012
    Date of Event
    August 22, 2012
    Report Date
    August 23, 2012
    Manufacturer
    KARDIUM INC.
    Product Code
    LXH
    Removal / Correction Number
    3009214225-08/28/2012-00
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L CATALOG #: 15-00001. THE MFR EVAL CODES WERE TAKEN FROM HTTP://WWW.FDA.GOV/MEDICALDEVICES/DEVICEREGULATIONANDGUIDANCE/GUIDANCEDOCUMENTS/UCM106742.HTM. KARDIUM OUTSOURCED THE MANUFACTURE OF THE TORQ DEVICES AFFECTED BY THIS RECALL TO THE FOLLOWING CONTRACT MFR. NAME: SOUTHMEDIC INC., (B)(4). MFR'S DEVICE EVAL SUMMARY: AFTER A TECHNICAL INVESTIGATION AND DEVICE HISTORY RECORD REVIEW, IT WAS DETERMINED THAT THE ROOT CAUSE OF THE DEFICIENCY WAS IMPROPER INSERTION OF THE LOCK WASHER INTO THE DEVICE BY A NEW, INEXPERIENCED OPERATOR. THE DEFICIENCY WAS FOUND TO BE LIMITED TO LOT 062711 AND NO OTHER LOTS ARE AFFECTED.

    Description of Event or Problem · 1

    ON (B)(6) 2012, KARDIUM REC'D A COMPLAINT REPORTING THAT A LOCK WASHER BECAME DISLODGED FROM A TORQ STERNAL CLOSURE DEVICE. THE METAL PART WAS FOUND BY THE SURGEON AFTER CLOSING THE PT, ON THE PT'S CHEST OUTSIDE OF THE INCISION. NO INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TORQ STERNAL CLOSURE DEVICE TWISTER, WIRE LXH KARDIUM INC. TQ01A 062711

    Patients

    Seq Age Sex Outcome Treatment
    1