BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VA LOCKSCR Ø2.4 SELF-TAP L18 TAN

    MDR report key: 3181239 · Received June 21, 2013

    Report

    Report Number
    8030965-2013-03763
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    January 20, 2012
    Report Date
    April 17, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    PMA / PMN Number
    K103243
    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. 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. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. THE VISUAL INVESTIGATION OF THE COMPLAINED SCREW SHOWS THAT THE LOCKING THREAD AT THE SCREW HEAD IS BADLY DAMAGED. IMPROPER CONTACT BETWEEN THE PLATE AND THE SCREW MAY HAVE CAUSED THE DAMAGED HEAD. IT IS POSSIBLE THAT MISALIGNMENT TO THE PLATE MAY BE THE ROOT CAUSE OF THE PROBLEM. FURTHER INVESTIGATION SHOWS FULL CONFORMITY OF THE IMPLANT TO THE SPECIFICATIONS. NO PRODUCT FAULT COULD BE DETECTED. THE INVESTIGATION DETERMINED THIS COMPLAINT TO BE INVALID. (B)(4).

    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. ADDITIONAL INFORMATION: THE DEVICE HISTORY RECORDS WERE REVIEWED, NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    THE SURGEON COULD NOT ROCK THE SCREW IN THE HOLE OF THE PLATE. THIS IS 1 OF 1 REPORT FOR THIS COMPLAINT (B)(4).

    Description of Event or Problem · 1

    THE SURGEON COULD NOT LOCK THE SCREW IN THE HOLE OF THE PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282809 VA LOCKSCR Ø2.4 SELF-TAP L18 TAN HWC SYNTHES GMBH 7549190

    Patients

    Seq Age Sex Outcome Treatment
    1