BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5MM CORTEX SCREW 26MM

    MDR report key: 4097743 · Received September 18, 2014

    Report

    Report Number
    1000562954-2014-10176
    Event Type
    Malfunction
    Date Received
    September 18, 2014
    Date of Event
    August 20, 2014
    Report Date
    August 21, 2014
    Manufacturer
    SYNTHES MEZZOVICO
    Product Code
    HWC
    PMA / PMN Number
    PK131186
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICE PRODUCT CODE: HRS. A DEVICE HISTORY REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THERE NO NCRS WERE GENERATED DURING PRODUCTION. THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A MANUFACTURING INVESTIGATION WAS CONDUCTED. THE REPORT INDICATES THAT THE MEASURABLE DIMENSION OF THE SCREW WAS AS FAR AS POSSIBLE CHECKED AND FOUND TO BE IN COMPLIANCE WITH THE TECHNICAL DRAWINGS AND AO/ASIF SPECIFICATION. THE EXAMINATION OF THE RAW-MATERIAL TESTING CERTIFICATE AND THE MANUFACTURING PAPERS SHOWED NO DEVIATIONS REGARDING MATERIAL ANALYSIS, STRENGTH AND STRUCTURAL STABILITY. THE VALUES WERE IN COMPLIANCE WITH AO/ASIF SPECIFICATION AND WITH THE INTERNATIONAL STANDARD ISO 5832-1. THE FRACTURE FACE OF THE SCREW IS HOMOGENOUS, WHICH INDICATES MATERIAL CONFORMITY AND HAS THE TYPICAL VIEW OF A FORCED RUPTURE. THE SCREW WITH THE LOT 1191529 WAS MANUFACTURED IN JUNE 2003 WITH A LOT SIZE OF (B)(4) PIECES. WE ARE NOT AWARE OF ANY OTHER COMPLAINT FOR THIS ARTICLE- AND LOT NUMBER. THE REMAINING THREAD OF THE SCREW WITH THE LOT 1191529 IS FLATTENED AND BENT, THE HEXAGON RECESS IS COMPLETELY STRIPPED. AN EXCESSIVE METALLIC CONTACT, PAR EXAMPLE WITH THE PLATE, CAUSED A MECHANICAL OVERLOAD. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE COMPLAINT RECEIVED STATES THAT THE SURGEON PLACED A DISTAL TIBIA PLATE ON THE PATIENT AND INSERTED TWO CORTICAL SCREWS IN THE OPTIMUM POSITION. UNDER IMAGE INTENSIFIER HE DECIDED, THAT SLIGHTLY LONGER SCREWS WERE NECESSARY. DURING REMOVING THE FIRST SCREW IT SHEARED WITH FIVE THREADS ONLY PROXIMALLY LEFT AND THE REMAINDER IN THE BONE. THE EXACT SAME THING HAPPENED IN THE EXACT SAME PLACE WITH THE SECOND SCREW. THE OUTCOME WAS THAT THE PLATE WAS MOVED SLIGHTLY AND TWO LONGER SCREWS HAVE BEEN INSERTED. NOT IDEAL AS OPTIMUM REDUCTION AND POSITION WAS GAINED ON INITIAL PLACEMENT. IT WAS REPORTED THAT THE SURGERY WAS EXTENDED FOR 10 MINUTES DUE TO THE SCREW REMOVAL AND REALIGNMENT OF THE PLATE. THE BONE QUALITY WAS REPORTED AS NORMAL. THIS IS REPORT NUMBER 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577899 3.5MM CORTEX SCREW 26MM SCREW,FIXATION,BONE HWC SYNTHES MEZZOVICO 1191529

    Patients

    Seq Age Sex Outcome Treatment
    1