BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLAVICLE FRACTURE PLATE, CENTRAL THIRD, RIGHT, SS

    MDR report key: 3924725 · Received July 10, 2014

    Report

    Report Number
    1220246-2014-00120
    Event Type
    Injury
    Date Received
    July 10, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 20, 2014
    Manufacturer
    ARTHREX, INC.
    Product Code
    HTN
    PMA / PMN Number
    K112437
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT DEMOGRAPHICS (AGE AT TIME OF EVENT, GENDER) 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. THE DEVICE WAS RECEIVED AND AN EVALUATION WAS CONDUCTED. THE COMPLAINT WAS CONFIRMED. DEVICE HISTORY RECORD REVIEW REVEALED NOTHING RELEVANT TO THIS EVENT. THE EVALUATION REVEALED THE PLATE BROKE APPROXIMATELY AT CLAVICLE DISTAL OR SHOULDER SIDE. THE FRACTURE FACE RUNS DIAGONALLY THROUGH ONE OF THE LATERAL OBLONG HOLES. THE SURFACE OF THE FRACTURE FACE APPEARS TO BE UNIFORM WITH SOME WORN OUT AREAS LOCATED LATERALLY. THE DEVICE MET ALL MATERIAL SPECIFICATIONS AS RECEIVED. BASED ON THE EVENT DESCRIPTION, WHERE IT WAS NOTED THAT THE DEVICE FAILED SOMETIME BETWEEN 8 AND 10 WEEKS POST-OPERATIVELY AND THE STATEMENT THAT THE PATIENT WAS HEALING WITH NO CLAVICLE FRACTURE AT THE TIME OF REMOVAL, THE MOST LIKELY CAUSES FOR THE COMPLAINANT'S EVENT INCLUDE IN-VIVO LOADING OF THE DEVICE POSSIBLY CAUSING A FATIGUE FRACTURE AS WELL AS PATIENT NON-COMPLIANCE WITH THE POST-OP PROTOCOL. PER PRODUCT DIRECTIONS FOR USE, POST-OPERATIVELY, UNTIL BONE HEALING IS COMPLETE, FIXATION GIVEN WITH THIS DEVICE SHOULD BE CONSIDERED AS TEMPORARY AND MAY NOT WITHSTAND WEIGHT BEARING OR OTHER UNSUPPORTED STRESS. POST-OPERATIVELY, UNTIL HEALING IS COMPLETE 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 IMPLANT. IN ADDITION, IT IS APPARENT THAT THE DEVICE WAS BENT PRIOR TO IMPLANTATION, AND AS STATED IN THE DFU, REPEATED BENDING OF THE PLATE AT THE SAME LOCATION, OR BY CREATING EXCESSIVE ACUTE ANGLES MAY POTENTIALLY LEAD TO PREMATURE PLATE FATIGUE, FAILURE AND OR BREAKAGE IN SITU. 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 THERE WAS A REVISION SURGERY FROM A RIGHT CLAVICLE FRACTURE REPAIR. THE PLATE BROKE IN HALF. PATIENT STATED THAT THERE WERE NO INJURY OR FALL THAT WOULD RESULT IN THE PLATE BREAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403144 CLAVICLE FRACTURE PLATE, CENTRAL THIRD, RIGHT, SS WASHER, BOLT NUT HTN ARTHREX, INC. 6791239

    Patients

    Seq Age Sex Outcome Treatment
    1 40 Other