BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLAVICLE FRACTURE PLATE, CENTRAL THIRD, RIGHT, STAINLESS STEEL

    MDR report key: 6692683 · Received July 7, 2017

    Report

    Report Number
    1220246-2017-00243
    Event Type
    Injury
    Date Received
    July 7, 2017
    Date of Event
    May 26, 2017
    Report Date
    July 7, 2017
    Manufacturer
    ARTHREX, INC.
    Product Code
    HTN
    UDI-DI
    00888867027435
    PMA / PMN Number
    K112437
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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. THE DEVICE MET ALL MATERIAL SPECIFICATIONS AS RECEIVED. THE EVALUATION REVEALED THE PLATE BROKE APPROXIMATELY AT THE MEDIAL SECTION. THE FRACTURE FACE RUNS DIAGONALLY THROUGH ONE OF THE LATERAL OBLONG HOLES. FEATURES OBSERVED ON THE FRACTURE SURFACE ARE TYPICALLY SEEN ON METAL FRACTURE DUE TO METAL FATIGUE FROM BENDING STRESS THAT EXCEEDED THE FATIGUE STRENGTH OF THE MATERIAL. DEVICE HISTORY RECORD REVIEW REVEALED NOTHING RELEVANT TO THIS EVENT. BASED ON THE EVENT DESCRIPTION AND OBSERVED EVIDENCE, THE MOST LIKELY CAUSE FOR THE COMPLAINANT'S EVENT WAS IN-VIVO LOADING OF THE DEVICE POSSIBLY CAUSING A FATIGUE FRACTURE AND/OR PATIENT NON-COMPLIANCE WITH THE POST-OP PROTOCOL. PER PRODUCT DIRECTIONS FOR USE (DFU-0192), POST-OPERATIVELY, UNTIL HEALING IS COMPLETE, FIXATION PROVIDED BY THIS DEVICE SHOULD BE CONSIDERED AS TEMPORARY AND MAY NOT WITHSTAND WEIGHT BEARING OR OTHER UNSUPPORTED STRESS. THE FIXATION PROVIDED BY THIS DEVICE SHOULD BE PROTECTED. THE POSTOPERATIVE REGIMEN PRESCRIBED BY THE PHYSICIAN SHOULD BE STRICTLY FOLLOWED TO AVOID ADVERSE STRESSES APPLIED TO THE DEVICE. THIS IS THE SECOND 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 ON (B)(6) 2017, THE PATIENT UNDERWENT A CLAVICLE FRACTURE PROCEDURE WHERE A CLAVICLE FRACTURE PLATE (LOT: 5231615, LINE 197326) WAS IMPLANTED. THE PATIENT HAD REPORTED TO SURGEON THAT HE WAS DRIVING, HAD TO HIT HIS BRAKES, AND THE PLATE BROKE. THE PLATE WAS REMOVED ON (B)(6) 2017 AND REPLACED WITH ANOTHER MANUFACTURER'S PLATE. ALL ORIGINAL SCREWS WERE ALSO EXPLANTED. SCREW PART AND LOT NUMBERS WERE NOTE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473838 CLAVICLE FRACTURE PLATE, CENTRAL THIRD, RIGHT, STAINLESS STEEL WASHER, BOLT, NUT HTN ARTHREX, INC. 5261615 00888867027435

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Other