BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VA LOCKSCR Ø2.4 SELF-TAP L18 TAN

    MDR report key: 3131833 · Received May 29, 2013

    Report

    Report Number
    2520274-2013-02936
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    April 17, 2013
    Report Date
    May 2, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    PMA / PMN Number
    K102694
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE INVESTIGATION OF THE COMPLAINED LOCKING SCREW SHOWS THAT THE SCREW HEAD IS SHARED OFF FROM THE SHAFT DUE TO EXCESSIVE APPLIED MECHANICAL FORCE. THE MEASURABLE DIMENSIONS ARE IN CONFORMANCE WITH THE SPECIFICATIONS. THE BROKEN SURFACE IS HOMOGENOUS WHAT INDICATES MATERIAL CONFORMITY. WE HAVE TO ASSUME THAT OVERLOADING SITUATION CAUSED THE BREAKAGE DUE TO HIGH APPLIED TORSIONAL FORCE WHICH MAY HAVE BEEN NEEDED TO EXTRACT THE SCREW. PLACEHOLDER.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING AN EXTRACTION OF AN UNKNOWN TCP IMPLANT ON (B)(6) 2013, THE ULNAR SCREW WAS DISCOVERED TO BE BROKEN. REPORTEDLY, THE DOCTOR STATED THAT THE ULNAR SIDE WAS MOST STRESSED DURING THE REHABILITATION, SO THE SCREW MIGHT HAVE BROKEN DUE TO METAL FATIGUE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236940 VA LOCKSCR Ø2.4 SELF-TAP L18 TAN HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1