BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROFX OCD UNIVERSAL DRILL

    MDR report key: 6664015 · Received June 23, 2017

    Report

    Report Number
    0002936485-2017-00603
    Event Type
    Malfunction
    Date Received
    June 23, 2017
    Date of Event
    May 25, 2017
    Report Date
    September 20, 2017
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    HTW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE MANUFACTURE DATE IS NOT KNOWN AT THIS TIME. HOWEVER, SHOULD IT BECOME AVAILABLE IT WILL BE PROVIDED IN FUTURE REPORTS. ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION THEREFORE THE REPORTED FAILURE MODE WAS NOT CONFIRMED. THE REPORTED FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE. ALLEGED FAILURE: PNR-DRILL BROKE OFF WHEN USING IN HIP ARTHROSCOPY. PROBABLE ROOT CAUSE: DESIGN: DRILL TOO DULL OR DULLS QUICKLY, INEFFICIENT FLUTE DESIGN, REQUIRES EXCESSIVE FORCE TO ADVANCE. DRILL NOT IN ALIGNMENT WITH GUIDE. DRILL ALLOWED TO EXTEND TOO FAR OUT OF GUIDE. PROCESS: DRILL MANUFACTURED OUT OF SPECIFICATION. DRILL GUIDE MANUFACTURED OUT OF SPECIFICATION. APPLICATION: EXCESSIVE AXIAL FORCE ON DRILL. RUN DRILL IN REVERSE. REUSE/RESTERILIZATION OF SINGLE-USE DEVICE, OR USE OF A SINGLE DRILL ON MULTIPLE DEFECTS. GUIDE IS TRANSLATED AND/OR ROTATED DURING DRILLING; DRILL NOT IN ALIGNMENT WITH GUIDE. USER DOES NOT USE SNAP CAP, DRILLS TOO DEEP. DRILL IS STARTED/STOPPED WHILE IN BONE (TECHNIQUE GUIDE INSTRUCTS TO RUN CONTINUOUSLY DURING DRILLING). THE DEVICE MANUFACTURE DATE IS NOT KNOWN. GTIN:(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED DRILL BROKE DURING USE.

    Description of Event or Problem · 1

    IT WAS REPORTED DRILL BROKE DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446335 MICROFX OCD UNIVERSAL DRILL BIT, DRILL HTW STRYKER ENDOSCOPY-SAN JOSE 14376

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR