BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEX DRIVER 1/4" SQUARE QC 4.0

    MDR report key: 8011010 · Received October 26, 2018

    Report

    Report Number
    3009051471-2018-00011
    Event Type
    Malfunction
    Date Received
    October 26, 2018
    Date of Event
    January 31, 2018
    Report Date
    December 14, 2022
    Manufacturer
    CTL MEDICAL CORPORATION
    Product Code
    FZT
    Removal / Correction Number
    300905147108022018-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PLIER TYPE - PIN CUTTER BLADE AT THE FOREMOST DISTAL TIP SEPARATED FROM THE CUTTING EDGET. NO HARM OR INJURY TO THE PATIENT WAS REPORTED. NO ADDITIONAL INFORMATION REGARDING SURGICAL TECHNIQUE WAS PROVIDED. CASE CAN BE CONSIDERED INCIDENTAL AND BE POTENTIALLY ATTRIBUTED TO WEAR AND TEAR AND/OR USER ERROR JUDGING FROM THE LOCATION OF THE FAILURE IT IS FOREMOST TIP INDICATING THAT THE SUBSTRATE WAS NOT PROPERLY POSITIONED INSIDE THE CUTTING BLADE REGION, BUT USING PARTIAL TIP ENGAGEMENT TO CUT THE SUBSTRATE. WITHOUT FURTHER INFORMATION, HOWEVER, CASE IS INDETERMINATE. PREVIOUS SUBMISSION UNDER THE SAME NAME WAS COMPLETED (3009051471-2018-00011) - ADDITIONAL AND MORE SUFFICIENT INFORMATION IS BEING PROVIDED FOR REVIEW.

    Additional Manufacturer Narrative · 1

    DEVICES WERE RECALLED FOLLOWING A COMPLAINT ON THE HEX DRIVER MISSING THE RETENTION RING. OUT OF ALL THE RECALLED DEVICES, THE LOT 7EQBB-C HAD 6 DEVICE MALFUNCTION. RETENTION RINGS FOR THE 6 DEVICES WERE FOUND MISSING. AFTER CORRESPONDENCE WITH THE FDA, 6 DIFFERENT MDRS ARE BEING FILED FOR THE 6 DEVICES THAT MALFUNCTIONED IN THE LOT. THIS IS THE #2 REPORT # (B)(4).

    Description of Event or Problem · 1

    PARTS WERE RETURNED FROM SITE AND WERE MISSING THE RETENTION RING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    850832 HEX DRIVER 1/4" SQUARE QC 4.0 PIN CUTTER FZT CTL MEDICAL CORPORATION 100.7013 17AE.SIAA
    850833 HEX DRIVER 1/4" SQUARE QC 4.0 PIN CUTTER FZT CTL MEDICAL CORPORATION 100.7013 17AE.SIAA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown