BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HALLU FIX

    MDR report key: 478433 · Received August 14, 2003

    Report

    Report Number
    478433
    Event Type
    Injury
    Date Received
    August 14, 2003
    Date of Event
    August 6, 2003
    Report Date
    August 6, 2003
    Manufacturer
    WRIGHT MEDICAL CO
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 10/1/03: WRIGHT MEDICAL TECHNOLOGY, INC IS NOT THE MFR OF THIS PRODUCT BUT THE DISTRIBUTOR. THE PRODUCT IS MFG BY NEW DEAL, INC. THUS WRIGHT IS FORWARDING A COPY OF LETTER TO THE NEW DEAL OFFICE LOCATED AT: NEW DEAL, INC., 2317 BRASSINGTON LANE, PLANO, TX 75075.

    Description of Event or Problem · 1

    SURGEON WAS INSERTING SCREW WHILE PERFORMING OSTEOTOMY OF 5TH METATARSAL. SCREW WAS A HALLUFIX SNAP OFF SCREW THAT THE TOP PORTION FAILED TO SNAP OFF. IN THE PROCESS OF SNAPPING THE SCREW TOP OFF, THE BONE CRACKED. THE SURGICAL PROCEDURE REQUIRED DIFFERENT REPAIR THAN WAS PLANNED.

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 10/03/03: MFR HAS BEEN INFORMED THAT WRIGHT MEDICAL TECHNOLOGIES RECEIVED A COPY OF USER FACILITY REPORT UNDER THE MEDICAL DEVICE REPORTING REGULATION (21 CFR 803). THIS MDR IS DUE TO A NEWDEAL'S PRODUCT, BRAND: HALLUFIX, GENERIC: HALLUFIX SNAP-OFF SCREW, PRODUCT CODE: SCREW, FIXATION, BONE. CATALOG NUMBER: 117 012 AND LOT NUMBER B206. MFR HAS NOT PREVIOUSLY SUBMITTED A MEDWATCH REPORT FOR THIS EVENT. MFR WOULD LIKE TO ADD MORE INFO ABOUT THE PRODUCT AND THE SURGICAL TECHNIQUE. FOR THE 5TH METATARSAL OSTEOSYNTHESIS MFR THINKS THAT THE DIAMETER, THE LENGTH AND THE TORQUE OF THIS PRODUCT ARE NOT ADAPTED WITH THE SURGICAL PROCEDURE. IN THIS CASE OTHER PRODUCTS WITH THINNER DIAMETER ARE MORE ADAPTED WITH THE BONE SIZE. IN CASE OF THE SURGEON WOULD LIKE TO USE THIS SURGICAL PROCEDURE, SURGEON SHOULD TAKE CARE OF THE SNAP-OFF SCREW AND ADAPT THE SURGICAL GESTURE BY CUTTING THE SNAP-OFF COMPONENT WITH A FORCEPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HALLU FIX HALLU FIX SNAP OFF SCREW HWC WRIGHT MEDICAL CO B206 *

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention