BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLAVICLE FRACTURE PLATE, CENTRAL THIRD, RIGHT, SS

    MDR report key: 4574854 · Received March 6, 2015

    Report

    Report Number
    1220246-2015-00053
    Event Type
    Injury
    Date Received
    March 6, 2015
    Date of Event
    December 13, 2013
    Report Date
    March 13, 2014
    Manufacturer
    ARTHREX, INC.
    Product Code
    HTN
    PMA / PMN Number
    K112437
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP SUBMISSION IS TO ADD A DEVICE LOT NUMBER, LOT 6791233. THE LOT NUMBER WAS UNKNOWN IN THE INITIAL SUBMISSION. DEVICE HISTORY RECORD REVIEW FOR THIS LOT REVEALED NOTHING RELEVANT TO THIS EVENT. THIS IS THE FIRST COMPLAINT OF THIS TYPE FOR THIS PART/LOT COMBINATION. 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 REQUESTED FOR EVALUATION BUT WAS NOT RETURNED, THEREFORE THE COMPLAINANT'S EVENT COULD NOT BE VERIFIED. THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. IF THE DEVICE IS RETURNED AND ADDITIONAL INFORMATION IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED. A MOST LIKELY CAUSE OF THE COMPLAINANT'S EVENT IS PATIENT NON-COMPLIANCE WITH THE POST-OP PROTOCOL. PER PRODUCT DIRECTIONS FOR USE (DFU-(B)(4)), 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.

    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. THE DEVICE WAS REQUESTED FOR EVALUATION BUT WAS NOT RETURNED, 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. DEVICE HISTORY RECORD REVIEW REVEALED NOTHING RELEVANT TO THIS EVENT. THE MOST LIKELY CAUSE(S) OF THIS TYPE OF EVENT INCLUDE PRYING/LEVERAGING THE DRIVER WHILE THE IMPLANT IS STILL LOADED, PREPARING A PILOT HOLE THAT IS TOO SMALL, INSERTING THE IMPLANT AT AN ANGLE NOT CO-AXIAL TO THE PILOT HOLE, OR APPLYING EXCESSIVE FORCE TO THE SCREW DURING IMPLANTATION. 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. DEVICE DISCARDED BY THE FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF THE DRIVER HAD BROKEN OFF IN THE IMPLANT AND REMAINED IN THE PATIENT. CASE WAS ON THE FOOT AND WAS COMPLETED SUCCESSFULLY. PATIENT IS DOING FINE TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2013, THE PATIENT SUFFERED AN INJURY TO HIS RIGHT SHOULDER WHILE RIDING HIS FOUR-WHEELER. THE REPAIR WAS PERFORMED WITH AN ARTHREX CLAVICLE PLATE AND QUICK FIX BONE PUTTY. IN A FOLLOW UP VISIT ON (B)(6) 2013, PATIENT WAS DOING WELL, DISCUSSED RESTRICTIONS. FOLLOW UP VISIT ON (B)(6) 2013, 2 WEEKS POST-OP, THE PLATE APPEARED TO BE BROKEN. HOWEVER, THE REPAIR WAS IN EXCELLENT CONDITION, AND PATIENT AGAIN INSTRUCTED TO LIMIT ALL ACTIVITY OF THE SHOULDER FOR FEAR THAT THE FRACTURE MIGHT DISPLACE. FOLLOW UP VISIT ON (B)(6) 2013, IT WAS NOTED THAT THE FRACTURE HAD DISPLACED ALONG WITH THE PLATE. REVISION SURGERY ON (B)(6) 2013. THE BROKEN PLATE WAS REMOVED AND WAS REPLACED WITH TWO CLAVICLE PLATES FROM A DIFFERENT MANUFACTURER ALONG WITH BONE PUTTY ALLOGRAFT. FOLLOW UP VISIT ON (B)(6) 2014 PATIENT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157600 CLAVICLE FRACTURE PLATE, CENTRAL THIRD, RIGHT, SS WASHER, BOLT NUT HTN ARTHREX, INC. 6791233

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other