BEUDAMED
    FDA Adverse Event Summary report: N

    RASP LIBERATOR KNIFE II, 4.75 X 149MM

    MDR report key: 5265108 · Received December 3, 2015

    Report

    Report Number
    1017294-2015-00077
    Date Received
    December 3, 2015
    Date of Event
    October 5, 2015
    Report Date
    November 10, 2015
    Manufacturer
    CONMED LINVATEC
    Product Code
    HTS
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVOLVED RASP LIBERATOR KNIFE II IS EXPECTED BUT HAS NOT YET BEEN RECEIVED FOR AN EVALUATION. A FOLLOW-UP SUBMISSION WILL BE FILED ONCE THE DEVICE HAS BEEN RECEIVED AND THE EVALUATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE INVOLVED RASP LIBERATOR KNIFE II WAS RECEIVED FOR AN EVALUATION ON 06-JAN-2015. A VISUAL INSPECTION OF THE RETURNED DEVICE VERIFIED THAT THE BREAKAGE OCCURRED AT THE TIP OF THE BLADE. A METALLURGIST STUDIED THE BREAK AND NOTED THAT THE MATERIAL IS STRONG BUT BRITTLE. THERE IS NO EVIDENCE OF POROSITY. IT DOES NOT APPEAR THAT THE BREAK IS RELATED TO THE MATERIAL OR MANUFACTURING PROCESS. THE BREAK APPEARS TO BE THE RESULT OF MISUSE OF THE DEVICE. LOT# 250956 WAS MANUFACTURED ON 10-MAR-2011. THIS IS A REUSABLE MANUAL INSTRUMENT OVER 4.5 YEARS OLD THAT IS CLEANED AND STERILIZED BETWEEN USES. A TWO YEAR REVIEW OF COMPLAINT HISTORY SHOWS NO SIMILAR REPORTS FOR THIS PRODUCT. THIS FAILURE MODE IS ADDRESSED IN THE FMEA, AND THE SAFETY RISK HAS BEEN FOUND TO BE ACCEPTABLE. THE IFU PROVIDES THE FOLLOWING CAUTIONS: INSPECT INSTRUMENTS PRIOR TO USE TO ENSURE PROPER FUNCTION; NO LOOSE PINS OR MISALIGNMENT, AND THAT THE INSTRUMENT IS IN GOOD PHYSICAL CONDITION. INSPECT INSTRUMENTS AFTER USE TO ENSURE IT HAS NOT BEEN DAMAGED. DO NOT USE EXCESSIVE FORCE ON INSTRUMENTS TO AVOID DAMAGE OR BREAKAGE DURING USE. AVOID UNINTENDED CONTACT WITH OTHER SURGICAL INSTRUMENTS DURING USE TO PREVENT DAMAGE OR BREAKAGE.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE RASP LIBERATOR KNIFE II BLADE BROKE DURING USE IN A SHOULDER SUPERIOR LABRUM ANTERIOR TO POSTERIOR (SLAP) REPAIR. THE BROKEN PORTION WAS RETRIEVED FROM THE SHOULDER WHICH CONTRIBUTED TO A 20-MINUTE DELAY. AS REPORTED, NO PATIENT INJURY OCCURRED AND THE PROCEDURE WAS COMPLETED AS INTENDED. THERE HAS BEEN NO ADDITIONAL INFORMATION RECEIVED REGARDING THE PATIENT'S LATEST CONDITION OR ANY INDICATION THAT A LONG TERM ADVERSE EFFECT HAS OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    796404 RASP LIBERATOR KNIFE II, 4.75 X 149MM RASP HTS CONMED LINVATEC 250956

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other