BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOW PROFILE SELF-TAPPING BONE SCREW 6.5 MM X 30 MM

    MDR report key: 2042541 · Received April 6, 2011

    Report

    Report Number
    1825034-2011-00261
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    March 10, 2011
    Report Date
    March 10, 2011
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    PMA / PMN Number
    K991807
    Removal / Correction Number
    1825034-2011-006R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DECISION WAS MADE TO RECALL BASED ON A MANUFACTURING ISSUE THAT WAS DETERMINED AS PART OF INTERNAL INVESTIGATION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT HIP PROCEDURE ON (B)(6) 2011. DURING THE PROCEDURE, THE SCRUB TECH OPENED A THIRTY MILLIMETER SCREW PACKAGE AND THOUGHT THAT THE SCREW INSIDE SEEMED SHORT. THE SCREW WAS MEASURED AND DETERMINED TO BE TWENTY-FIVE MILLIMETERS INSTEAD OF THE THIRTY MILLIMETERS LABELED ON THE PACKAGING. THE SURGEON DETERMINED THIS LENGTH WAS STILL ACCEPTABLE FOR THE PROCEDURE HE WAS PERFORMING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOW PROFILE SELF-TAPPING BONE SCREW 6.5 MM X 30 MM PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A 502360

    Patients

    Seq Age Sex Outcome Treatment
    1