BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONE SCREWS DIA. 6.5 X H. 20MM

    MDR report key: 5046327 · Received September 1, 2015

    Report

    Report Number
    3008021110-2015-00037
    Event Type
    Malfunction
    Date Received
    September 1, 2015
    Date of Event
    July 28, 2015
    Report Date
    August 6, 2015
    Manufacturer
    HPF
    Product Code
    LPH
    PMA / PMN Number
    K112898
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO ANOMALIES DETECTED BY CHECKING THE MANUFACTURING CHARTS OF THE DEVICE INVOLVED. NO OTHER COMPLAINTS RECEIVED ON THESE LOT #. WE WILL RECEIVE AND ANALYZE THE SCREW AND THE SCREWDRIVER INVOLVED, AND THEN SUBMIT A FINAL EMDR WITH ADDITIONAL FINDINGS. DEVICE NOT RECEIVED YET.

    Additional Manufacturer Narrative · 1

    NO ANOMALIES DETECTED BY CHECKING THE DHR PROVIDED BY THE MANUFACTURER (HPF) OF THE SCREWDRIVER INVOLVED; NO ANOMALY DETECTED BY CHECKING THE DHR OF THE SCREW INVOLVED. NO OTHER COMPLAINTS RECEIVED ON THESE LOT # ON A TOTAL OF (B)(4) SCREWS AND (B)(4) SCREWDRIVERS MANUFACTURED WITH THE THESE LOT #. WE NEVER RECEIVED THE SCREWDRIVER AND SCREW INVOLVED. A DEEP INVESTIGATION WAS THEREFORE NOT POSSIBLE. NO CORRECTIVE ACTION PLANNED FOR THIS SPECIFIC CASE. LIMACORPORATE WILL KEEP MONITORING THE MARKET ON THE REOCCURRENCE OF THIS EVENT.

    Description of Event or Problem · 1

    DURING SURGERY, PERFORMED IN (B)(6) ON THE (B)(6) 2015, AFTER TIGHTENING THE BONE SCREW TO FIX THE ACETABULAR CUP TO THE ACETABULUM, THE SURGEON COULD NOT REMOVE THE SCREWDRIVER (NOT MARKETED IN THE US) FROM THE SCREW (MARKETED IN THE US). SURGERY TIME PROLONGED OF 15 MINUTES DUE TO THE ISSUE.

    Description of Event or Problem · 1

    DURING SURGERY, PERFORMED IN (B)(6) ON THE (B)(6) 2015, AFTER TIGHTENING THE BONE SCREW TO FIX THE ACETABULAR CUP TO THE ACETABULUM, THE SURGEON COULD NOT REMOVE THE SCREWDRIVER (DEVICE NOT MARKETED IN THE US) FROM THE SCREW (DEVICE MARKETED IN THE US). SURGERY TIME PROLONGED OF 15 MINUTES DUE TO THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579041 BONE SCREWS DIA. 6.5 X H. 20MM BONE SCREW LPH HPF 8420.15.010 201507050

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization