BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, CANCELLOUS

    MDR report key: 6975634 · Received October 25, 2017

    Report

    Report Number
    1220246-2017-00394
    Event Type
    Injury
    Date Received
    October 25, 2017
    Date of Event
    August 24, 2017
    Report Date
    October 25, 2017
    Manufacturer
    ARTHREX INC.
    Product Code
    HRS
    UDI-DI
    00888867010574
    PMA / PMN Number
    K032187
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT DEMOGRAPHICS (AGE AT TIME OF EVENT, DATE OF BIRTH, GENDER, WEIGHT) WERE REQUESTED BUT NOT PROVIDED. NO FURTHER PATIENT INFORMATION WAS PROVIDED AT THE TIME OF THIS REPORT OR MADE AVAILABLE IN RESPONSE TO FOLLOW-UP COMMUNICATION. NO ADDITIONAL ADVERSE CONSEQUENCES HAVE BEEN REPORTED FROM THIS EVENT. THIS DEVICE IS USED FOR TREATMENT. THIS IS ONE OF SEVEN SUBMISSIONS FROM THE SAME SINGLE EVENT. THE OTHERS ARE CC126231-LINE 208645-00392, CC126231-LINE 210798-00393, CC126231-LINE 210802-00395, CC126231-LINE 210803-00396, CC126231-LINE 210804-00397 AND CC126231-LINE 210805-00398. DEVICE HISTORY RECORD REVIEW REVEALED NOTHING RELEVANT TO THIS EVENT. THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION THEREFORE THE COMPLAINANT'S EVENT COULD NOT BE VERIFIED. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. THIS IS THE FIRST COMPLAINT OF THIS TYPE FOR THIS PART/LOT COMBINATION. THE POTENTIAL CAUSES OF THIS EVENT ARE BEING COMMUNICATED TO THE EVENT REPORTER. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2017, THE PATIENT UNDERWENT A DISTAL FEMORAL OSTEOTOMY PROCEDURE WHERE THE FOLLOWING DEVICES WERE IMPLANTED: CORTICAL SCREW, AR-13380-34 (LOT: 10140529, LINE 208645), AR-13110R-01 (LOT: 10129525, LINE 210798), AR-13370-1 (LOT: M16906P016, LINE 210799), AR-13370-2 (LOT: M16914C015, LINE 210800), AR-13280-55 (LOT: 10122391, LINE 210801), AR-13380-44 (LOT: 10124044, LINE 210802) AR-13380-46, (LOT: 10084866, LINE 210803), AR-13380-38 (LOT: 10136981, LINE 210804), AND, AR-13880-36 (LOT: 10136979, LINE 210805) INTO THE PATIENT'S FEMUR. DURING THE PROCEDURE, AN AP X-RAY WAS TAKEN WITH NO INDICATIONS OF ANY ABNORMALITIES. ON (B)(6) 2017, THE PATIENT CAME IN FOR A POST-OP CHECK-UP WHERE A LATERAL X-RAY WAS TAKEN SHOWING A FRACTURE IN THE PATIENT'S FEMUR. THE PATIENT HAS NOT EXPERIENCED ANY PAIN OR DISCOMFORT. THE SURGEON IS GOING TO KEEP THE PATIENT NON-WEIGHT BEARING FOR A FEW MORE WEEKS. PATIENT IS A FEMALE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    757334 SCREW, CANCELLOUS PLATE, FIXATION, BONE HRS ARTHREX INC. 10122391 00888867010574

    Patients

    Seq Age Sex Outcome Treatment
    1 Other