BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 4210211 · Received October 29, 2014

    Report

    Report Number
    2520274-2014-14030
    Event Type
    Injury
    Date Received
    October 29, 2014
    Report Date
    October 2, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    A SIMPLE TECHNIQUE FOR REMOVING A LOCKING COMPRESSION PLATE WITH A STRIPPED LOCKING SCREW. KIM, SEOK-JUNG., KIM, MIN-UP., J ORTHOP TRAUMA, VOLUME 26, NUMBER 6, JUNE 2012. (B)(4). INVESTIGATION COULD NOT BE COMPLETED AND 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 SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE. A SIMPLE TECHNIQUE FOR REMOVING A LOCKING COMPRESSION PLATE WITH A STRIPPED LOCKING SCREW. KIM, SEOK-JUNG., KIM, MIN-UP., J ORTHOP TRAUMA, VOLUME 26, NUMBER 6, JUNE 2012. THIS IS A RETROSPECTIVE REVIEW OF 2 PATIENTS AND A STRAIGHTFORWARD TECHNIQUE TO REMOVE A LOCKING COMPRESSION PLATE (LCP) AND SCREW WITH A STRIPPED HEXAGONAL RECESS. LOCKING COMPRESSION PLATES (LCP; SYNTHES, PAOLI, PA) ARE NOW WIDELY VIEWED AS THE STANDARD METHOD FOR FRACTURE TREATMENT, AND SOME PROMISING CLINICAL REPORTS SUPPORT THIS TREND. HOWEVER, ALONG WITH THEIR INCREASED USE, SOME OF THEIR LIMITATIONS ARE ALSO BECOMING EVIDENT, ESPECIALLY THOSE REGARDING THEIR REMOVAL. THEREFORE, WE DESCRIBE A SIMPLE, EFFECTIVE METHOD OF REMOVING A LOCKING COMPRESSION PLATE WITH A STRIPPED LOCKING SCREW. IF THE HEXAGONAL RECESS OF THE SCREW HAD BEEN STRIPPED DURING ATTEMPTS AT SCREW REMOVAL USING A CONICAL EXTRACTION DEVICE, WE PERFORM THE FOLLOWING PROCEDURE AFTER LOOSENING THE CONTACT SURFACE BETWEEN THE BONE AND THE PLATE. USING A LARGER DRILL BIT, ANOTHER HOLE IS DRILLED IMMEDIATELY ADJACENT TO THE SCREW THROUGH THE NON-LOCKING PORTION OF THE COMBINATION HOLE. THE PLATE IS STRUCK ALONG THE LINE CONNECTING THE SCREW TO THE NEWLY FORMED HOLE. USING AN ELEVATOR, LEVERAGE FORCE IS THEN APPLIED TO THE PLATE, WHICH CAN BE REMOVED WITH THE STRIPPED SCREW ATTACHED. THIS TECHNIQUE CAN BE USED TO REMOVE PLATES WITH SEVERAL STRIPPED SCREWS AND DOES NOT REQUIRE ANY SPECIAL TOOLS. THIS REPORT IS FOR A (B)(6) FEMALE PATIENT WHO HAD A DISTAL TIBIA FRACTURE AND OPEN REDUCTION AND INTERNAL FIXATION. ONE YEAR POSTOPERATIVELY, THE PATIENT ELECTED TO UNDERGO IMPLANT REMOVAL AS A RESULT OF DISCOMFORT OVER THE MEDIAL MALLEOLUS. REMOVAL OF THE LCP WAS PERFORMED; HOWEVER, ONE OF THE LOCKING SCREWS WAS STRIPPED. THE STRIPPED SCREW AND PLATE WERE SUCCESSFULLY REMOVED USING THE DESCRIBED TECHNIQUE. THIS REPORT IS 4 OF 4 PARTS FOR (B)(4) THIS REPORT IS FOR AN UNKNOWN LOCKING SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693167 SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention