BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Y-KNOT ALL SUTURE ANCHOR DRILL BIT

    MDR report key: 3050411 · Received April 10, 2013

    Report

    Report Number
    1017294-2013-00013
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    March 14, 2013
    Report Date
    March 14, 2013
    Manufacturer
    CONMED LINVATEC
    Product Code
    GFG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVOLVED DRILL BIT IS NOT EXPECTED FOR EVALUATION, AS IT WAS ALREADY DISPOSED OF AT THE USER FACILITY. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED LOT #412400 WAS MANUFACTURED ON NOVEMBER 5, 2012 IN A LOT OF 50 UNITS WITH NO NOTED DISCREPANCIES DURING THE MANUFACTURING PROCESS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED BREAKAGE. THERE WAS ONE OTHER SIMILAR COMPLAINT RECEIVED FROM THE SAME CUSTOMER FOR THIS ITEM AND LOT NUMBER COMBINATION. THIS IS A RELATIVELY NEW DEVICE, WHICH IS VERY TECHNIQUE DEPENDENT. WITHOUT THE INVOLVED PRODUCT THE EVALUATION COULD NOT BE PERFORMED OR DETERMINED IF A MALFUNCTION HAD OCCURRED. HOWEVER, SIMILAR COMPLAINTS REVEALED THAT THE MOST LIKELY CAUSE OF THIS SUSPECTED FAILURE IS USER-RELATED. THIS FAILURE MODE IS ADDRESSED IN THE DFMEA, AND THE SAFETY RISK HAS BEEN FOUND TO BE ACCEPTABLE. TO REDUCE THE RISK OF DRILL BIT BREAKAGE AND INJURY TO THE PATIENT, THE INSTRUCTION FOR USE (IFU) PROVIDED THE FOLLOWING WARNINGS AND PRECAUTIONS: PRIOR TO USE, REMOVE ALL PROTECTIVE PACKAGING AND TIP PROTECTOR, IF APPLICABLE. INSPECT INSTRUMENTS PRIOR TO USE TO ENSURE THEY ARE IN GOOD PHYSICAL CONDITION. THERE SHOULD BE NO LOOSE, BROKEN OR MISALIGNED PARTS. INSPECT INSTRUMENTS AFTER USE TO ENSURE THEY HAVE NOT BEEN DAMAGED. DO NOT USE EXCESSIVE FORCE ON INSTRUMENTS TO AVOID DAMAGE OR BREAKAGE DURING USE.\ - DO NOT USE INSTRUMENTS TO PRY, AS BENDING OR BREAKAGE MAY OCCUR. EXERCISE CARE WHEN USING THE DRILL BIT AND DRILL GUIDE. APPLYING SIDE OR BENDING LOADS MAY CAUSE DRILL BIT BREAKAGE, OVERSIZED TUNNEL OR GENERATION OF METAL PARTICULATES. DO NOT RE-SHARPEN, RE-STERILIZE, OR REUSE. SOME INSTRUMENTS MAY BE EXTREMELY SHARP. HANDLE WITH CARE TO AVOID INJURY. THE DRILL BIT IS SINGLE USE AND MUST BE DISPOSED ACCORDING TO HOSPITAL POLICY AND PROCEDURES.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING USE OF THIS Y-KNOT ALL-SUTURE ANCHOR DRILL BIT (HF13D) IN A SHOULDER STABILIZATION (ANTERIOR) PROCEDURE ON A (B)(6), MALE PATIENT, THE TIP OF THE DRILL BIT BROKE OFF IMMEDIATELY. THE BROKEN TIP WAS REMOVED, THE SURGERY WENT ON AND COMPLETED AS INTENDED WITHOUT ANY FURTHER COMPLICATION. OTHER THAN A SHORT DELAY OF APPROXIMATELY 10 MINUTES TO REMOVE THE BROKEN TIP, THERE WAS NO SERIOUS INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149325 Y-KNOT ALL SUTURE ANCHOR DRILL BIT BIT, SURGICAL GFG CONMED LINVATEC 412400

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR HF13A Y-KNOT ALL SUTURE ANCHOR, LOT #: UNKNOWN