BEUDAMED
    FDA Adverse Event Injury Summary report: N

    *

    MDR report key: 552427 · Received August 27, 2004

    Report

    Report Number
    MW1033471
    Event Type
    Injury
    Date Received
    August 27, 2004
    Date of Event
    August 18, 2004
    Report Date
    August 27, 2004
    Manufacturer
    INTEGRA LIFESCIENCES CORP
    Product Code
    HTX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IT WAS CONFIRMED THAT THE PRODUCT PART NUMBER WAS 280-405. THE LOT NUMBER WAS NOT VISIBLE ON THE DEVICE. THE DEVICE WAS NOT RETURNED FROM THE HOSPITAL FOR INVESTIGATION. HOWEVER, SOME PHOTOS TAKEN BY PATIENT'S LEGAL COUNCIL HAVE BEEN PROVIDE FOR INVESTIGATION. PHOTOGRAPHS AND PERTINENT INFORMATION HAVE BEEN FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THE FOLLOWING IS THE INVESTIGATION RESULT OBTAINED FROM THE MANUFACTURER: THE PHOTOS CLEARLY SHOW THE BROKEN SECTION OF THE JAW WHICH WAS RETRIEVED, BUT HINGE PIN WAS MISSING. THE BREAK IN THE HINGE SECTION APPEARED TO BE CLEAN WITH NO VISIBLE STRESS FRACTURES. THE OVERALL CONDITION OF THE INSTRUMENT APPEARED POOR, WITH SIGNIFICANT SURFACE SCRATCHES AND CHIPS MISSING FROM BOTH FINGER HOLES. THERE WAS ALSO "06/03" MARKED ON THE REAR FINGER HOLE EXTENSION. THIS IS NOT JARIT MARKING AND COULD HAVE BEEN MADE BY A INSTRUMENT REPAIR VENDOR NOT ASSOCIATED WITH JARIT INSTRUMENT. THE ROOT CAUSE COULD NOT BE DETERMINED WITHOUT EXAMINATION OF THE ACTUAL INSTRUMENT. THE DEVICE HISTORY RECORD WITHOUT A SPECIFIC LOT NUMBER WAS REVIEWED FROM 1998 TO PRESENT, INSTRUMENTS WERE PRODUCED, AND THERE WERE NO ANY FDA REPORTABLE EVENTS SUBMITTED BY THE MANUFACTURER.

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 2/7/05: INTEGRA LIFESCIENCES DID NOT BECOME AWARE OF THIS INCIDENT UNTIL JANUARY 13, 2005, INTEGRA LIFESCIENCES, OWNER/OPERATOR OF J. JAMNER SURGICAL INSTRUMENTS, FILED A DISTRIBUTOR MEDICAL DEVICE REPORT TO FDA ON JANUARY 18, 2005. J. JAMNER SURGICAL INSTRUMENTS DOES NOT ASSIGN LOT OR SERIAL NUMBERS TO THESE CLASS I SURGICAL INSTRUMENTS. INTEGRA LIFESCIENCES, ON BEHALF OF J. JAMNER SURGICAL INSTRUMENTS, INC., FILED A MEDWATCH DISTRIBUTOR REPORT ON JANUARY 18, 2005. THIS REPORT REFERENCES MDR NUMBER 2430952-2005-00005 (ATTACHED). J. JAMNER SURGICAL INSTRUMENTS HAS NOT BEEN ABLE TO IDENTIFY THE MANUFACTURER OF THE INSTRUMENT SINCE THE INSTRUMENT WAS NOT RETURNED TO J. JAMNER SURGICAL INSTRUMENTS FOR INVESTIGATION. MULTIPLE ATTEMPTS HAVE BEEN MADE BY THE QUALITY ASSURANCE PERSONNEL AT J. JAMNER SURGICAL INSTRUMENTS TO OBTAIN ADD'L INFO FROM THE USER FACILITY. THEY WILL CONTINUE TO WORK WITH THE CUSTOMER TO COLLECT ADD'L INFO TO IDENTIFY THE MANUFACTURER OF HE INSTRUMENT.

    Description of Event or Problem · 1

    DURING SPINAL SURGERY, PIECE OF BLADE FROM PITUITARY RONGEUR BROKE OFF. SCREW ALSO CAME OUT OF INSTRUMENT. REQUIRED INCISION TO BE OPENED AND THE BROKEN TIP REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * PITUITARY RONGEUR HTX INTEGRA LIFESCIENCES CORP 280-405 *

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention