BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOLOC(TM) 3.5 X 16 LOCKING SCREW

    MDR report key: 3952144 · Received May 12, 2014

    Report

    Report Number
    1043534-2014-00128
    Event Type
    Malfunction
    Date Received
    May 12, 2014
    Date of Event
    April 2, 2014
    Report Date
    April 2, 2014
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A REPORTABLE MALFUNCTION. THE INVESTIGATION IS NOT COMPLETE. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2014-00127.

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION FOUND THAT THE SCREW DOES HAVE THREAD PEELING FROM THE SCREW. ANALYSIS OF THE RETURNED PRODUCT FOUND THE SCREW TO BE WITHIN SPECIFICATION. ANALYSIS OF THE RETURNED PRODUCT INDICATES THAT THE SCREW COULD HAVE BEEN A CONTRIBUTOR TO THE REPORTED EVENT. THE SCREW HAS PEELING THREAD INDICATING THAT IT MAY HAVE BEEN INSERTED THROUGH THE PLATE AT AN INCORRECT ANGLE CAUSING THE THREAD TO PEEL. BASED ON ANALYSIS, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. HOWEVER THE MOST LIKELY ROOT CAUSE WAS USER TECHNIQUE.

    Description of Event or Problem · 1

    ALLEGEDLY THREADS "PEELING" OFF SEVERAL SCREWS (LOCK AND NON LOCK) WHILE INSERTED INTO RIGHT MEDIUM LATERAL FIBULA PLATE. THE IMPLANTATION SITE WAS THE LATERAL FIBULA FRACTURE AND THE ISSUE WAS RESOLVED BY SWAPPED SCREWS. THE SALES REP WAS PRESENT AT THE PROCEDURE; SURGERY WAS NOT EXTENDED MORE THAN 30 MINS; INCIDENT OCCURRED DURING SURGERY. EMAILED SALES REP ((B)(4)) ON (B)(4) 2014 FOR PRODUCT INFORMATION, TRACKING # FOR PRODUCTS BEING SENT BACK AND IF SHE HAD ANY KNOWLEDGE OF THE HOSPITAL FILING A MDR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284282 ORTHOLOC(TM) 3.5 X 16 LOCKING SCREW SMALL JOINT COMPONENT HWC WRIGHT MEDICAL TECHNOLOGY, INC. NI

    Patients

    Seq Age Sex Outcome Treatment
    1