BEUDAMED
    FDA Adverse Event Other Summary report: N

    DE PUY ORTHO TECHNOLOGY

    MDR report key: 252329 · Received December 1, 1999

    Report

    Report Number
    MW1017669
    Event Type
    Other
    Date Received
    December 1, 1999
    Date of Event
    November 18, 1999
    Report Date
    December 1, 1999
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    HTO
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ON 11/18/99, IN OR, WHILE DR WAS USING A DOUBLE-PRONGED RETRACTOR DURING HIP SURGERY, ONE OF THE TIPS BROKE OFF (PENCIL LEAD SIZE). THIS INSTRUMENT IS USED DURING HIP SURGERY TO DISLOCATE DISEASED HIP, THEN FORCEFULLY PRESSED AGAINST METAL IMPLANT TO PLACE NEW HIP. DURING THIS FORCING INTO TIGHT AREA, SNAP WAS HEARD, TIP NOTED MISSING FROM INSTRUMENT. X-RAY DONE WITH C-ARM - FOREIGN BODY NOTED. DR WAS UNABLE TO LOCATE IT TO REMOVE IT, STATED IT WILL NOT CAUSE ANY HARM. IT WAS LEFT IN PT. THE INSTRUMENT #2176-10, MANUFACTURED BY DEPUY ORTHO TECHNOLOGY, INC WAS REMOVED FROM SVC AND WILL BE REPLACED. INSTRUMENT WAS PURCHASED IN 1993. A WRITTEN REPORT WILL BE SENT TO THE MFR AND THE RETRACTOR WILL BE SENT TO THEM UPON RECEIPT OF A SIGNED RELEASE FORM. THERE HAD BEEN NO PREVIOUS PROBLEMS WITH THIS RETRACTOR. REPORT SENT TO MFR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DE PUY ORTHO TECHNOLOGY DOUBLE PRONGED RETRACTOR HTO DEPUY ORTHOPAEDICS, INC. 2176-10 *

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other