BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONICAL EXTRACTION SCREW

    MDR report key: 3032701 · Received April 3, 2013

    Report

    Report Number
    1719045-2013-00884
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 5, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HWC
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH 4.5MM LCP LOCKING CONDYLAR PLATE, LOCKING SCREWS AND CORTICAL SCREWS (UNKNOWN HOW MANY SCREWS THE PATIENT WAS IMPLANTED WITH) ON AN UNKNOWN DATE. PATIENT WAS RETURNED TO THE O.R. ON (B)(6) 2013 FOR REMOVAL OF HARDWARE TO FREE UP THE SCARRED DOWN QUADRICEPS MECHANISM SO PATIENT CAN HAVE MORE NORMAL FUNCTION OF LEG. PATIENT HEALED THE ORIGINAL FRACTURE AND THEY REMOVED HARDWARE WHILE THEY WERE THERE AS PLANNED FOR THIS PROCEDURE. PRIOR TO REMOVING THE HARDWARE, ONE OF THE 4.5MM CORTEX SCREWS OF UNKNOWN LENGTH WAS NOTICED TO BE BROKEN NEAR THE TOP OF THE PLATE; BROKEN IN THE PROXIMAL SHAFT OF THE FEMUR. THE HEAD PORTION OF THE SCREW WAS REMOVED UNEVENTFULLY AND THE SHAFT OF THE SCREW WAS LEFT IN THE FEMUR SO AS TO HELP AVOID A SUB-TROCHANTERIC FEMUR FRACTURE LATER. THE SURGEON DECIDED TO LEAVE THE BROKEN SCREW IMPLANTED. DURING THE HARDWARE REMOVAL IN THE LEFT DISTAL FEMUR, ONE OF THE 5.0MM CANNULATED LOCKING SCREWS WAS STUCK BECAUSE THE HELICAL HEX WAS STRIPPED. THE SURGEON WAS USING THE CONICAL EXTRACTION SCREW INSTRUMENT TO ATTEMPT REMOVAL OF THE STRIPPED 5.0MM CANNULATED LOCKING SCREW AND THE DEVICE BROKE OFF INSIDE THE LOCKING SCREW. BOTH THE CONICAL EXTRACTION SCREW TIP AND THE STRIPPED LOCKING SCREW WERE THEN DRILLED OUT WITH A CARBIDE TIPPED DRILL BIT AND THE PLATE WAS REMOVED SUCCESSFULLY. REMOVAL OF THE STRIPPED LOCKING SCREW DID EXTEND THE SURGERY BY MORE THAN 15 MINUTES. THIS IS 1 OF 4 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136590 CONICAL EXTRACTION SCREW HWC SYNTHES MONUMENT UP52642

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention