BEUDAMED
    FDA Adverse Event Injury Summary report: N

    Y-KNOT ALL SUTURE ANCHOR DRILL BIT

    MDR report key: 3152355 · Received June 7, 2013

    Report

    Report Number
    1017294-2013-00022
    Event Type
    Injury
    Date Received
    June 7, 2013
    Date of Event
    May 16, 2013
    Report Date
    May 20, 2013
    Manufacturer
    CONMED LINVATEC
    Product Code
    GFG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVOLVED DRILL BIT IS NOT EXPECTED FOR EVALUATION, AS THE TIP REMAINS IN THE PATIENT'S SHOULDER AND THE REMAINDER PORTION WAS DISPOSED OF AT THE USER FACILITY. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED LOT #418303 WAS MANUFACTURED ON NOVEMBER 5, 2012 IN A LOT OF 100 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 USER FACILITY 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 AND ROOT CAUSE OF THIS BREAKAGE COULD NOT BE DETERMINED. 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) PROVIDES 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. DEVICE WAS DISCARDED AT USER/FACILITY.

    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 ARTHROSCOPY BANKART REPAIR PROCEDURE AND AS THE SURGEON WAS DRILLING A HOLE FOR THE ANCHOR, THE TIP OF THE DRILL BIT BROKE OFF. THE BROKEN TIP REMAINS LODGED IN THE GLENOID, AS THE SURGEON FELT IT WOULD HAVE BEEN TOO DIFFICULT TO REMOVE. THE SURGEON ELECTED TO LEAVE THE BROKEN PORTION IN PLACE AND PROCEEDED WITH THE CASE BY USING A NEW DRILL BIT. OTHER THAN ONE MINUTE DELAY, THE SURGERY WAS COMPLETED AS INTENDED WITHOUT ANY FURTHER COMPLICATION OR SERIOUS INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252945 Y-KNOT ALL SUTURE ANCHOR DRILL BIT BIT, SURGICAL GFG CONMED LINVATEC 418303

    Patients

    Seq Age Sex Outcome Treatment
    1 Other PRO6202M MPOWER2 2-TRIGGER HP. SN#: UNK