BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LONG HELIX DRILL D.3,5MM

    MDR report key: 6116079 · Received November 21, 2016

    Report

    Report Number
    3008021110-2016-00068
    Event Type
    Malfunction
    Date Received
    November 21, 2016
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    HTW
    PMA / PMN Number
    CLASS I
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DHR: THE CHECK OF THE DHR OF THE LOT # INVOLVED (201505795) DID NOT SHOW ANY PRE-EXISTING ANOMALY ON THE 148 HELIX DRILL MANUFACTURED WITH THIS LOT #. PMS DATA: ACCORDING TO OUR PMS DATA, 16 COMPLAINTS FOR A TOTAL OF 18 BREAKAGES WERE REPORTED ON THE V.00 HELIX DRILLS WITH PRODUCT CODES 9084.20.081 AND 9084.20.086 ON A TOTAL OF (B)(4) V.00 HELIX DRILL MANUFACTURED WITH THE PRODUCT CODES INVOLVED. HELIX DRILLS INVOLVED IN THESE COMPLAINTS WERE MANUFACTURED ACCORDING TO SPECIFICATIONS . BREAKAGE OF DRILL BITS IS A COMMON AND EXPECTED OCCURRENCE IN ORTHOPAEDIC SURGERY SINCE TWISTING OF THE BIT AND TORQUE ACCIDENTALLY APPLIED BY THE SURGEON DURING DRILLING CAN LEAD TO BREAKAGE OF THE DRILL. CAPAS: IN MAY 2016, AFTER RECEIVING SIMILAR COMPLAINTS, LIMACORPORATE DECIDED TO MODIFY THE TECHNICAL DRAWINGS OF THE HELIX DRILLS WITH PRODUCT CODES 9084.20.081 - 9084.20.086, BY INCREASING THE CORE DIAMETER OF THE INSTRUMENTS (V.01 HELIX DRILLS). THIS PRODUCT ENHANCEMENT WAS INTRODUCED IN ORDER TO INCREASE THE HELIX DRILLS MECHANICAL STRENGTH AND REDUCE THE RISK OF OCCURRENCE OF INTRA-OP BREAKAGE. LIMACORPORATE WILL KEEP MONITORING THE MARKET TO VERIFY THE EFFECTIVENESS OF THE ABOVE CORRECTIVE ACTION. THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    INTRA-OPERATIVE BREAKAGE OF HELIX DRILL (PRODUCT CODE 9084.20.086, LOT #201505795). DRILL BITS BROKE WHILE THE SURGEON WAS DRILLING THE GLENOID. NO IMPACT ON SURGERY AND NO CONSEQUENCES FOR THE PATIENT. EVENT OCCURRED IN US.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    770391 LONG HELIX DRILL D.3,5MM LONG HELIX DRILL DIA 3.5MMX79MM HTW LIMACORPORATE S.P.A. 9084.20.086 1505795

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown