BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUMERAL SUTUREPLATE, 5-HOLE, TITANIUM

    MDR report key: 4234130 · Received November 7, 2014

    Report

    Report Number
    1220246-2014-00221
    Event Type
    Injury
    Date Received
    November 7, 2014
    Date of Event
    October 9, 2014
    Report Date
    October 20, 2014
    Manufacturer
    ARTHREX, INC.
    Product Code
    HRS
    PMA / PMN Number
    K041965
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT DEMOGRAPHICS (DATE OF BIRTH, 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 RECEIVED AND AN EVALUATION WAS CONDUCTED. THE COMPLAINT WAS CONFIRMED. DEVICE HISTORY RECORD REVIEW REVEALED NOTHING RELEVANT TO THIS EVENT. THE EVALUATION OF THE RETURNED DEVICE REVEALED THAT THERE WERE FOUR BUSHINGS MISSING FROM HOLES. THE FOUR LOOSE BUSHINGS WERE RETURNED WITH THE HUMERAL SUTURE PLATE, TWO OF THEM COMPLETELY LOOSE IN A PLASTIC BAG AND TWO STILL ATTACHED TO THE SCREW HEADS. ALL THE REMAINING BUSHINGS WERE RETURNED IN THE ASSOCIATED H HOLES OF THE HUMERAL PLATE. MULTIPLE SCRATCHES AND DENTS WERE OBSERVED ON THE PLATE SURFACE NEARBY THE HOLE AREAS. THREADS IN THE BUSHINGS REMAINING IN THEIR ASSOCIATED HOLES WERE OBSERVED TO BE DAMAGED AND/OR STRIPPED. THREADS ON THE HEAD OF SOME OF THE SCREWS WERE ALSO NOTICED TO BE STRIPPED. THIS COMPLAINT IS STILL UNDER INVESTIGATION. AT THE CURRENT TIME THE CAUSE OF THE EVENT CANNOT BE DETERMINED. IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED FROM THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A SUTUREPLATE FAILURE. IN THE POST-OP X-RAY, IT LOOKS LIKE THE DISTAL SCREWS DIDN'T HAVE GOOD BI-CORTICAL PURCHASE, BUT THE CENTRAL SCREW IN WHICH THE COLLET AND SCREW PULLED THOUGH THE PLATE IS THE BIG ISSUE. X-RAY PROVIDED BY THE SURGEON. PATIENT DID NOT FALL AND NO FORCE WAS PUT ON THE ARM. FOLLOW-UP: REVISION SURGERY WAS ORIGINALLY SCHEDULED FOR (B)(6) 2014 BUT WAS POSTPONED BECAUSE THE PATIENT HAD AN INFECTION (NOT RELATED TO THIS PROCEDURE OR INCIDENT). SURGEON WANTED THE INFECTION CLEARED UP PRIOR TO THE REVISION. ADDITIONAL INFORMATION RECEIVED: THE REVISION SURGERY TOOK PLACE (B)(6) 2014. ALL ARTHREX'S PARTS, HUMERAL SUTUREPLATE AND SCREWS WERE FULLY REMOVED. SURGEON USED QUICKSET AND BONE GRAFT TO FILL THE BONE JOINT AND THEN USED ANOTHER MANUFACTURER'S SUTUREPLATE AND SCREWS TO COMPLETE THE REVISION PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    718040 HUMERAL SUTUREPLATE, 5-HOLE, TITANIUM PLATE, FIXATION, BONE HRS ARTHREX, INC. 600451

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other