BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINVATEC HALL

    MDR report key: 474994 · Received July 29, 2003

    Report

    Report Number
    474994
    Event Type
    Malfunction
    Date Received
    July 29, 2003
    Date of Event
    July 17, 2003
    Report Date
    July 28, 2003
    Manufacturer
    LINVATEC
    Product Code
    HWE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING LEFT TOTAL KNEE REPLACEMENT THE BONE SAW CAME APART AND LOOSE SAW PARTS FELL INTO THE STERILE AREA WHILE THE PHYSICIAN WAS SAWING. THE DEVICE SEPARATED AT THE TREADED AREA ABOVE THE BLADE LOCKING MECHANISM. THE STERILE AREA WAS CLEANED AND THE PT WAS GIVEN ANTIBIOTICS AS A PRECAUTIONARY MEASURE.

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 9/9/03: RESPONSE: THE CUSTOMER CONTACTED LINVATEC ON JULY 17, 2003 AN REPORTED THAT THE "OPEN/CLOSE LEVER OR NUT CAME OFF AND LANDED IN THE STERILE FIELD DURING PROCEDURE" FOR PRODUCT, 00-5071-002-00 VERSIPOWER PLUS OSCILLATING SAW. THE REPORTER ALSO ADVISED THIS WAS DURING A TOTAL KNEE AND REPORTED, "SOME DELAY". ON AUGUST 4, 2003, LINVATEC RECEIVED A MEDWATCH REPORT FROM THE CUSTOMER THAT WAS NUMBERED 0034272-2003-0001. THE CUSTOMER DESCRIBED EVENT AS: "DURING LEFT TOTAL KNEE REPLACEMENT THE BONE SAW CAME APART AND LOOSE SAW PARTS FELL INTO THE STERILE AREA WHILE THE PHYSICIAN WAS SAWING. THE DEVICE SEPARATED AT THE THREADED AREA ABOVE THE BLADE LOCKING MECHANISM. THE STERILE AREA WAS CLEANED AND THE PT WAS GIVEN EXTRA ANTIBIOTICS AS A PRECAUTIONARY MEASURE." THE CUSTOMER REPORTED NO INJURY. LINVATEC DOES NOT CONSIDER THIS EVENT AN MDR REPORTABLE EVENT. THE REPORTER AND THE MEDWATCH DID NOT REPORT A DEATH OR AN ALLEGATION OF A SERIOUS INJRY. AFTER THE REPORTER CALLED EXPLAINING THAT DEVICE COMPONENTS HAD DETACHED DURING USE, THE ACTUAL DEVICE WAS RECEIVED AT LINVATEC ON JULY 23, 2003. MFR DOES NOTE IN ITS COMPLAINT FILED THAT THE, 00-5071-002-00 VERSIPOWER PLUS OSCILLATING SAW WAS LAST SENT TO LINVATEC FOR SERVICE IN APRIL 2002. THIS EVENT IN JULY 2003 IS 3 MONTHS PAST ITS RECOMMNEDED PREVENTIVE MAINTENANCE INTERVAL. AS PART OF THE LINVATEC SERVICE PROGRAM, MFR DOES INSPECT ALL ATTACHMENTS TO PRODUCT SPECIFICATIONS AND REPAIR OR REPLACE PARTS/COMPONENTS DURING NORMAL SERVICE RETURNS AND ALSO DURING NORMAL PREVENTATIVE MAINTENANCE (PM) INTERVALS. AS DOCUMENTED IN ITS SERVICE/COMPLAINT FILE, THIS DEVICE WAS OUT OF THE PRESCRIBED MAINTENANCE INTERVAL. WHEN RECEIVED, THE HEAD ASSEMBLY WAS BROKEN, THE MOTOR EXHIBITED INTERNAL CORROSION FROM USE, AND THE TRIGGER ASSEMBLY REQUIRED PREVENTATIVE MAINTENANCE. ALL COMPONENTS WERE SERVICED OR REPLACED AND THE DEVICE WAS RETURNED TO THE CUSTOMER. BASED UPON THE SERVICE EVALUATION FINDINGS, MFR COULD NOT DETERMINE THAT A MALFUNCTION HAD OCCURRED. AS THERE WAS NO INJURY REPORTED, LINVATEC DOES NOT CONSIDER THE USE OF EXTRA ANTIOBIOTICS DURING OR AFTER SURGERY IS A RECOGNIZED STANDARD OF CARE EVENT FOR SURGERIES WHERE THERE ARE NO ADVERSE EVENTS REPORTED. AS PREVIOUSLY INDICATED, LINVATEC RECEIVED A MEDWATCH REPORT FROM THE FACILITY IN JULY 2003 FOR THIS EVENT AND ENTERED THE REPORT INTO ITS COMPLIANT HANDLING SYSTEM UNDER RG NUMBER 713201. LINVATEC HAS CLOSED THE COMPLAINT AND CONSIDERS THE FILE COMPLETE WITH NO FURTHER ACTION REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINVATEC HALL BONE SAW HWE LINVATEC VP+; 5071-002 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other