BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKSCR Ø5 SELF-TAP L40 TAN

    MDR report key: 3194165 · Received June 27, 2013

    Report

    Report Number
    8030965-2013-04045
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    December 14, 2011
    Report Date
    January 21, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    KTT
    PMA / PMN Number
    K000682
    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. (B)(6). DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. THE INVESTIGATION OF THE COMPLAINED DEVICES SHOWED THAT THE LOCKING HEADS OF THE SCREWS WERE STRONGLY BLOCKED INSIDE THE THREADED HOLE OF THE PLATE. THE THREADS ARE COMPLETELY WORN OUT. PERHAPS THAT TOO MUCH MECHANICAL FORCE APPLIED WHILE TIGHTENING MAY HAVE CAUSED THE PROBLEM. PLEASE NOTE, THE USE OF THE TORQUE LIMITER IS STRONGLY RECOMMENDED DURING SCREW INSERTION. NO PRODUCT DEFAULT COULD BE DETECTED.

    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. EXPIRATION DATE: 03/01/2020. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. REPORTED DATE: (B)(6) 2011. THIS IS SOLD IN THE U.S. NOT JUST THE (B)(6), K000682. PLACEHOLDER.

    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. ORIGINALLY REPORTED AWARENESS DATE IS CORRECT; PREVIOUS FOLLOW-UP ERRONEOUSLY CHANGED DATE.

    Description of Event or Problem · 1

    DIFFICULTY REMOVING SCREWS FROM THE PLATE ONE YEAR AFTER INITIAL SURGERY. THIS IS 3 OF 3 REPORTS FOR EVENT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293989 LOCKSCR Ø5 SELF-TAP L40 TAN KTT SYNTHES GMBH 2579658

    Patients

    Seq Age Sex Outcome Treatment
    1