BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCRDRIVER T8 SELF-HOLD ANGL W/SLEEVE

    MDR report key: 3171628 · Received June 15, 2013

    Report

    Report Number
    8030965-2013-03193
    Event Type
    Malfunction
    Date Received
    June 15, 2013
    Date of Event
    February 13, 2012
    Report Date
    February 20, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    OVE
    PMA / PMN Number
    K112068
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. (B)(6). THE DEVICE WAS RECEIVED AND IT WAS NOTED THAT THE TIP OF THE SCREWDRIVER WAS BROKEN. THE REVIEW OF THE PRODUCTION HISTORY REVEALED THAT THIS INSTRUMENT WAS MANUFACTURED IN MARCH 2009 ACCORDING TO SPECIFICATIONS. NO ABNORMAL FINDINGS WERE IDENTIFIED. THE BROKEN SURFACE IS HOMOGENOUS WHAT INDICATES MATERIAL CONFORMITY TO THE SPECIFICATION AS WELL. BASED ON THESE RESULTS WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCES AND IS INDICATIVE OF EXCEEDING APPLIED MECHANICAL FORCE LEADING TO THE BREAKAGE OF THE TIP.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN BELGIUM AS FOLLOWS: DURING A PROCEDURE ON (B)(6) 2012, THE TIP OF THE SCREWDRIVER STARDRIVE BROKE DURING INSERTION. THE TIP WAS RETRIEVED. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272461 SCRDRIVER T8 SELF-HOLD ANGL W/SLEEVE OVE SYNTHES GMBH 3107024

    Patients

    Seq Age Sex Outcome Treatment
    1