BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING DRILL EXTENDER

    MDR report key: 1693144 · Received May 4, 2010

    Report

    Report Number
    3005990499-2010-00004
    Event Type
    Malfunction
    Date Received
    May 4, 2010
    Date of Event
    April 7, 2010
    Report Date
    April 7, 2010
    Manufacturer
    KEYSTONE DENTAL
    Product Code
    NDP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL EXAMINATION OF THE RETURNED DEVICE CONFIRMS THE DRILL EXTENDER IS BROKEN AND CORRODED. THE MOST PROBABLE CAUSE OF THE REPORTED ISSUE IS CORROSION, AND NORMAL WEAR AND TEAR. KEYSTONE DENTAL INC. ALSO DETERMINED THAT THIS CUSTOMER PURCHASED THE DEVICE IN (B)(6) OF 2010. SPOKE WITH THE CUSTOMER AND THEY DO NOT KNOW HOW MANY TIMES THE DEVICE WAS USED. KEYSTONE DENTAL'S SURGICAL MANUAL RECOMMENDS DRILLS BE REPLACED WHEN WORN, CORRODED, DULL OR OTHERWISE COMPROMISED. FURTHER, THAT DRILLS SHOULD BE REPLACED AFTER APPROXIMATELY TWENTY (20) USES DEPENDING ON BONE DENSITY. IT IS LEFT TO THE PHYSICIAN TO TRACK INDIVIDUAL DEVICE USAGE. IT IS CONCLUDED THAT KEYSTONE DENTAL HAS LABELING INSTRUCTIONS ON HOW THE PRODUCT MAY BE USED SAFELY TO AVOID THIS EVENT. ENCLOSED IS A COPY OF KEYSTONE DENTAL'S MOST CURRENT WARRANTY POLICY LOCATED ON THE BACK OF THE KEYSTONE DENTAL CATALOG AND SURGICAL MANUAL INSTRUCTIONS. (B)(4).

    Description of Event or Problem · 1

    INITIAL REPORTER COMMUNICATED THAT DURING THE OSTEOTOMY PROCEDURE, THE LOCKING DRILL EXTENDER BROKE. THERE WAS NO PATIENT INTERVENTION OR ADVERSE EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOCKING DRILL EXTENDER NDP KEYSTONE DENTAL L1404-01K MM00415

    Patients

    Seq Age Sex Outcome Treatment
    1