BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, CORTICAL

    MDR report key: 6725291 · Received July 19, 2017

    Report

    Report Number
    1220246-2017-00271
    Event Type
    Injury
    Date Received
    July 19, 2017
    Date of Event
    July 5, 2017
    Report Date
    July 20, 2017
    Manufacturer
    ARTHREX, INC.
    Product Code
    HRS
    UDI-DI
    00888867011601
    PMA / PMN Number
    K032187
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    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 FOUR SUBMISSIONS FROM THE SAME EVENT. THE OTHERS ARE CC119282-LINE 199106-00270; CC119282-LINE 200051-00272 AND CC119282-LINE 200053-00273. 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 CAUSE(S) OF THIS EVENT WILL BE 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 THE FIRST SCREW (LINE 199106) CAUSED A VERTICAL FRACTURE OF THE FEMUR. A TOTAL OF 7 SCREWS WERE USED; THE FRACTURE GOT LONGER WITH EACH SCREW. THE CASE WAS FINISHED AND CERCLAGE WIRE WAS USED TO HOLD THE FEMUR TOGETHER. FEMORAL OSTEOTOMY. NO ADDITIONAL HOSPITALIZATION WAS NEEDED. FOLLOW-UP INVESTIGATION: IT WAS REPORTED THAT DURING A FEMORAL OSTEOTOMY CASE THE CONTOURLOCK FEMORAL OSTEO SMALL RIGHT PLATE, AR-13110R-01 (LINE 199105) WAS USED. WHEN IMPLANTING THE FIRST CORTICAL SCREW, AR-13380-54 (LINE 199106) IN THE MOST DISTAL OF THE PROXIMAL HOLES THE FEMUR BEGAN TO FRACTURE. THE FRACTURE CONTINUED AS THE SCREWS WERE IMPLANTED DISTAL TO PROXIMAL. THE SCREWS WERE IMPLANTED AS FOLLOWS: AR-13380-50 (LINE 200047), AR-13380-46 (LINE 200051) AND AR-13380-36 (LINE 200053). THE CASE WAS COMPLETED USING ANOTHER MANUFACTURE'S 18 GAUGE WIRE (QTY. 2) TO SECURE THE FRACTURE IN CERCLAGE TECHNIQUE. AT THIS TIME THE PATIENT HAS NOT HAD A POST OP RECHECK. PATIENT IS MALE, (B)(6).. NO ADDITIONAL HOSPITALIZATION WAS NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505870 SCREW, CORTICAL PLATE, FIXATION, BONE HRS ARTHREX, INC. 573103 00888867011601

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other