BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUPINE DRILL BIT

    MDR report key: 2060816 · Received March 11, 2011

    Report

    Report Number
    1221934-2011-00099
    Event Type
    Malfunction
    Date Received
    March 11, 2011
    Date of Event
    March 3, 2011
    Report Date
    March 3, 2011
    Manufacturer
    DEPUY MITEK
    Product Code
    HTW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NOTHING IS BEING RETURNED FOR EVALUATION AND NO LOT HAS BEEN IDENTIFIED, WHICH PRECLUDES CONDUCTING A BATCH RECORD REVIEW TO DETERMINE IF THERE WERE ANY INTERNAL PROCESSING ISSUES WHICH WOULD HAVE CONTRIBUTED TO THE NATURE OF THE PRODUCT COMPLAINT. HOWEVER, WE BELIEVE THAT THIS TYPE OF EVENT IS MOST LIKELY TECHNIQUE RELATED, EXTENSIVE LAB TESTING HAS SHOWN THAT UNDER NORMAL CONDITIONS THE REPORTED EVENT MODE COULD NOT BE DUPLICATED, HOWEVER, UNDER EXTREME CONDITIONS, THAT IS WHEN THE DRILL GUIDE WAS BENT DURING DRILLING WITH A DRILL BIT, THIS CAUSED THE DRILL BIT TO RUB AGAINST INNER SURFACE OF THE BENT DRILL GUIDE CAUSING SOME METAL TO SHAVE OFF OF THE DRILL GUIDE, THE REPORTED CONDITION WAS THEN DUPLICATED. OUTSIDE OF THIS HYPOTHESIS AND CONSIDERATION, WE CANNOT DISCERN ANY OTHER ROOT CAUSE FOR THE REPORTED ISSUE; AT THIS POINT IN TIME NO CORRECTIVE OR FURTHER ACTION IS WARRANTED, HOWEVER, WHEN THE COMPLAINT DEVICE IS REC'D HERE AT DEPUY MITEK IT WILL BE FORWARDED TO QUALITY ENGINEERING, WHERE IT WILL BE SUBJECTED TO A ROOT CAUSE FAILURE ANALYSIS. IF THE ANALYSIS IDENTIFIES ANY DEFINITIVE ROOT CAUSE A F/U REPORT WILL BE FILED.

    Description of Event or Problem · 1

    OUR REP IS REPORTING TO US THAT DURING AN ARTHROSCOPIC SHOULDER PROCEDURE THE SURGEON OBSERVED METAL SHAVINGS FALLING INTO THE PT'S BODY WITH THE USE OF 2 LUPINE DRILL BITS. ALL OF THE DEBRIS WAS REMOVED AND THE PROCEDURE WAS CONCLUDED SUCCESSFULLY WITHOUT FURTHER ISSUE OR HARM TO THE PT. THE COMPLAINT DEVICES WERE DISCARDED AT THE USER FACILITY. ALSO SEE ASSOCIATED MDR 1221934-2011-00098.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUPINE DRILL BIT ARTHROSCOPIC INSTRUMENT HTW DEPUY MITEK 211033 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK