BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DOUBLE COMPRESSION PLATE

    MDR report key: 6138118 · Received December 1, 2016

    Report

    Report Number
    1220246-2016-00534
    Event Type
    Injury
    Date Received
    December 1, 2016
    Date of Event
    November 7, 2016
    Report Date
    January 6, 2017
    Manufacturer
    ARTHREX, INC.
    Product Code
    HRS
    UDI-DI
    00888867042544
    PMA / PMN Number
    K130510
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. NO DEVICE MALFUNCTION IDENTIFIED. AT THIS TIME, IT CANNOT BE DETERMINED IF THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO ARTHREX. LOT NUMBER WAS NOT PROVIDED SO DEVICE HISTORY RECORD REVIEW CANNOT BE PERFORMED. AS STATED IN THE EVENT, PER SURGEON ,THE PATIENT STATED THAT HE MIGHT HAVE HAD TOO MUCH WEIGHT ON THE FOOT TOO EARLY. THE MOST LIKELY CAUSE(S) OF THIS TYPE OF EVENT INCLUDE NON-COMPLIANCE TO THE POST-OP PROTOCOL OR POST-OP TRAUMA TO THE SURGICAL SITE. PER DEVICE DIRECTIONS FOR USE, 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. DEVICE EXPECTED BUT NOT YET RECEIVED.

    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 A FOLLOW-UP SUBMISSION TO REFLECT DEVICE EVALUATION AND A CORRECTION TO THE DEVICE PART NUMBER. COMPLAINT CONFIRMED. THE DEVICE MET ALL MATERIAL SPECIFICATION AS RECEIVED. THE EVALUATION REVEALED THE RETURNED COMPRESSION PLATE IS BROKEN IN HALF. THE FRACTURE FACE DISPLAYS PLASTIC DEFORMATION. PER THE COMPLAINANT, THE PATIENT MAY HAVE PLACED WEIGHT ON THE FRACTURE SITE PREMATURELY. THE MOST LIKELY CAUSE(S) FOR THE COMPLAINANT'S EVENT INCLUDE IN-VIVO LOADING OF THE DEVICE POSSIBLY CAUSING A FATIGUE FRACTURE AND POSSIBLY IN CONJUNCTION WITH BENDING/STRESSING THE PLATE PRIOR TO IMPLANTATION AS WELL AS PATIENT NON-COMPLIANCE WITH THE POST-OP PROTOCOL. PER PRODUCT DIRECTIONS FOR USE (DFU-0192), 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 AND UNTIL HEALING IS COMPLETE THE FIXATION PROVIDED BY THIS DEVICE SHOULD BE PROTECTED. THE POST-OPERATIVE REGIMEN PRESCRIBED BY THE PHYSICIAN SHOULD BE STRICTLY FOLLOWED TO AVOID ADVERSE STRESSES APPLIED TO THE DEVICE. DAMAGE TO THE SCREW MOST LIKELY OCCURRED DURING PLATE EXTRACTION DUE TO IMPACT WITH ANOTHER DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2016 THE AR-8008-25, 4 HOLE DOUBLE COMPRESSION PLATE, WAS IMPLANTED. APPROXIMATELY 5 (FIVE) WEEKS AFTER INITIAL SURGERY, THE PLATE BROKE POST-OP. A REVISION SURGERY WAS DONE ON (B)(6) 2016 WHERE AN ARTHODESIS WAS PERFORMED WITH COMPRESSION SCREWS. PER SURGEON, THE PATIENT STATED THAT HE MIGHT HAVE HAD TOO MUCH WEIGHT ON THE FOOT TOO EARLY. BONE QUALITY UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2016 THE AR-8008-25, 4 HOLE DOUBLE COMPRESSION PLATE, WAS IMPLANTED. APPROXIMATELY 5 (FIVE) WEEKS AFTER INITIAL SURGERY, THE PLATE BROKE POST-OP. A REVISION SURGERY WAS DONE ON (B)(6) 2016 WHERE AN ARTHODESIS WAS PERFORMED WITH COMPRESSION SCREWS. PER SURGEON, THE PATIENT STATED THAT HE MIGHT HAVE HAD TOO MUCH WEIGHT ON THE FOOT TOO EARLY. BONE QUALITY UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    790468 DOUBLE COMPRESSION PLATE PLATE, FIXATION, BONE HRS ARTHREX, INC. UNKNOWN 00888867042544

    Patients

    Seq Age Sex Outcome Treatment
    1 Other