BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKSCR Ø2.7 HEAD LCP2.4 SELF-TAP L24 TA

    MDR report key: 3171573 · Received June 15, 2013

    Report

    Report Number
    8030965-2013-02822
    Event Type
    Malfunction
    Date Received
    June 15, 2013
    Date of Event
    June 16, 2011
    Report Date
    July 8, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE OR UNCHANGED. 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. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE INVESTIGATION OF THE COMPLAINED LOCKING SCREW SHOWS CONFORMITY TO SPECIFICATION. THE DIMENSIONS WERE CHECKED WITH MEASURING MACHINE AND ALL WERE FOUND TO BE WITHIN VALID TOLERANCES. WE ARE NOT ABLE TO DETERMINE THE EXACTLY REASON FOR THE REPORTED PROBLEM. NO PRODUCT FAULT COULD BE DETECTED. THE LOT NUMBER HAS BEEN PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORD IS NOT YET AVAILABLE.

    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. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. PLACEHOLDER.

    Description of Event or Problem · 1

    THE LOCKING SCREW WENT THROUGH THE PLATE HOLE. THIS IS 1 OF 2 REPORTS FOR THE COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272596 LOCKSCR Ø2.7 HEAD LCP2.4 SELF-TAP L24 TA HRS SYNTHES GMBH 3366126

    Patients

    Seq Age Sex Outcome Treatment
    1