BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 4775479 · Received May 15, 2015

    Report

    Report Number
    2520274-2015-13871
    Event Type
    Injury
    Date Received
    May 15, 2015
    Date of Event
    April 4, 2014
    Report Date
    May 12, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT FOR DIAGNOSIS. THIS REPORT IS FOR AN UNKNOWN HUMERUSBLOCK(UNKNOWN QUANTITY/UNKNOWN LOT. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE. CARBONE, S; ET.AL; (2014) THE AMOUNT OF HUMERAL HEAD IMPACTION OF PROXIMAL HUMERAL FRACTURES FIXED WITH THE HUMERUSBLOCK DEVICE. INTERNATIONAL ORTHOPAEDICS, 38, 1451-1459. THE HUMERUSBLOCK DEVICE (SYNTHES, (B)(4)) ENABLES PERCUTANEOUS KIRSCHNER-WIRE (K-WIRE) FIXATION OF DISPLACED FRACTURES OF THE PROXIMAL HUMERUS. A DRAWBACK OF THE DEVICE IS POSSIBLE K-WIRE PERFORATION OF THE HEAD WITH THE NEED FOR EARLY REMOVAL OF THE IMPLANT. BETWEEN MARCH 2011 AND JANUARY 2013, 46 CONSECUTIVE DISPLACED PROXIMAL HUMERUS FRACTURES WERE TREATED WITH CLOSED OR MINIMALLY-INVASIVE REDUCTION AND OSTEOSYNTHESIS USING THE HUMERUSBLOCK SYSTEM. THE HUMERUSBLOCK WAS REMOVED IN 18 CASES BECAUSE OF K-WIRES PERFORATION OF THE HUMERAL HEAD. IN ONLY ONE CASE, THE BLOCK OF THE DEVICE CAUSED LOCAL DISCOMFORT AND WAS REMOVED. ALL FRACTURES APPEARED TO BE HEALED AFTER EIGHT WEEKS OF SURGERY. THE RADIOGRAPHIC RESULT AT THE LATEST FOLLOW-UP WAS EXCELLENT IN 20, GOOD IN 13, FAIR IN SIX, POOR IN FOUR CASES. IN CONCLUSION, POSTOPERATIVE IMPACTION OF THE HUMERAL HEAD MAY ALLOW THE KWIRES OF THE HUMERUSBLOCK TO PERFORATE THE CORTEX OF THE HEAD, WHICH OCCURRED IN 41 % OF OUR PATIENTS, WHO NEEDED PROMPT REMOVAL OF THE IMPLANT. AN ORIGINAL METHOD WAS USED TO CALCULATE THE AMOUNT OF POSTOPERATIVE IMPACTION OF THE HEAD, WHICH WAS 3.9 MM ON AVERAGE. A MAXIMUM DISTANCE OF 5 MM BETWEEN THE TIP OF THE MOST CRANIAL K-WIRE AND THE CORTEX OF THE HUMERAL HEAD IS PROBABLY SAFE ENOUGH AS TO AVOID PERFORATION OF THE HEAD IN MOST PATIENTS TREATED WITH THE HUMERUSBLOCK WITHOUT PREDISPOSING TO POST-OPERATIVE LOSS OF REDUCTION. THIS REPORT IS 1 OF 1 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN HUMERUSBLOCK AND REFERS TO AN UNK PATIENT WHO EXPERIENCED A SERIOUS INJURY - LOCAL DISCOMFORT AND DEVICE REMOVAL. THERE WERE 18 REMOVALS DUE TO K-WIRE PERFORATION OF THE CORTEX OF THE HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318997 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention