BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACUFEX, CANNULATED DRILL BIT 4.5MM, STERILE

    MDR report key: 585894 · Received February 22, 2005

    Report

    Report Number
    1219602-2005-00031
    Event Type
    Other
    Date Received
    February 22, 2005
    Date of Event
    January 18, 2005
    Report Date
    February 19, 2005
    Manufacturer
    SMITH & NEPHEW, INC. ENDOSCOPY DIVISION
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING AN ACL REPAIR THE DRILL BIT BROKE INTO PIECES. THE STERILE INSTRUMENT TABLE WAS PREPARED BEFORE SALES REPRESENTATIVE FOR SMITH & NEPHEW ARRIVED. UNKNOWN TO DR. A REPROCESSED ENDOBUTTON DRILL BIT WAS PLACED ON THE TABLE. UPON DRILING, REP NOTICED THAT THE DRILL WAS NOT CUTTING. THE DISTAL TIP OF THE DRILL THEN BROKE INTO THREE PIECES. DR. WAS NOT ABLE TO RETRIEVE ALL THE PIECES. A NEW DRILL BIT PROVIDED BY REP WAS AVAILABLE AND USED TO COMPLETE THE PROCEDURE WITHOUT INCIDENT. POST SURGERY, THE NURSE INFORMED DR. AND REP THAT THE DRIL BIT WAS REPROCESSED. REP STATED THAT A ONE-HOUR DELAY TOOK PLACE. REP ALSO EMPHASIZED TO THE CUSTOMER THE IMPORTANCE OF NOT REPROCESSING OR RE-USING SINGLE USE DEVICES. REP DID NOT HEAR OF ANY COMPLICATIONS WITH THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUFEX, CANNULATED DRILL BIT 4.5MM, STERILE ENDO-CANN DRILL BIT HRX SMITH & NEPHEW, INC. ENDOSCOPY DIVISION 7207315 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other