BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL PROSTHESIS INSERTER/EXTRACTOR

    MDR report key: 2233492 · Received September 2, 2011

    Report

    Report Number
    1825034-2011-00767
    Event Type
    Injury
    Date Received
    September 2, 2011
    Date of Event
    July 19, 2011
    Report Date
    August 10, 2011
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    HWB
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE RETURNED DEVICE FOUND EVIDENCE TO SUGGEST HEAVY USAGE. THERE ARE SCRATCHES ALONG THE SHAFT ALONG WITH A CONCENTRATION OF SCRAPES AT THE HILT AS WELL AS NUMEROUS IMPACT MARKS ON THE STRIKE PLATE AND DISTAL SHAFT SCRAPES. THE POLYMER HANDLE HAS AN APPROXIMATELY ONE INCH TRIANGULAR FRACTURE; THE FRACTURE ARTIFACTS SUGGEST THE HANDLE HAD A POINT-LOAD IMPACT. (B)(4).

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE ASSOCIATED PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: "INTRAOPERATIVE FRACTURE OR BREAKING OF INSTRUMENTS HAS BEEN REPORTED. SURGICAL INSTRUMENTS ARE SUBJECT TO WEAR WITH NORMAL USAGE... BIOMET RECOMMENDS THAT ALL INSTRUMENTS BE REGULARLY INSPECTED FOR WEAR AND DISFIGUREMENT." (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT HIP ARTHROPLASTY PROCEDURE UTILIZING A FEMORAL PROSTHESIS INSERTER/EXTRACTOR ON (B)(6) 2011. DURING THE PROCEDURE, A PIECE OF THE INSERTER HANDLE FRACTURED. THE SURGEON RETRIEVED THE FRACTURED PIECE FROM THE PATIENT'S WOUND. THERE WAS NO INJURY TO THE PATIENT OR DELAY TO THE PROCEDURE AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FEMORAL PROSTHESIS INSERTER/EXTRACTOR EXTRACTOR HWB BIOMET ORTHOPEDICS N/A 007600

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R