BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKSCR Ø3.5 SELF-TAP L26 TAN

    MDR report key: 3173861 · Received June 17, 2013

    Report

    Report Number
    8030965-2013-03264
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    August 17, 2011
    Report Date
    September 13, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    KTT
    PMA / PMN Number
    K000684
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE ADDITIONAL EVALUATION REVEALED THAT THERE IS VISIBLE DAMAGE AND DEFORMATION ON THE SCREW RECESS. THE MEASURABLE DIMENSIONS OF THE RETURNED LOCKING SCREW WERE CHECKED AND FOUND TO BE IN COMPLIANCE WITH THE TECHNICAL DRAWINGS AND AO/ ASIF SPECIFICATION. DEFORMATION ON THE SCREW RECESS IS EVIDENCE THAT TOO MUCH MECHANICAL FORCE DURING TIGHTENING HAS LED TO THIS DEFAULT. NO MANUFACTURING PRODUCT FAULT COULD BE DETECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SCREW RECESS WAS DAMAGED DURING SURGERY. THE DOCTOR INSERTED THE LOCKING SCREW INTO THE BONE, WHEN THE SCREW TIP NEARLY REACHED THE OTHER SIDE OF THE CORTICAL BONE THE SCREW RECESS ON THE SCREW HEAD WAS DISCOVERED BROKEN. THE DOCTOR TOOK THIS SCREW OUT AND INSERTED A DIFFERENT SCREW OF THE SAME LENGTH WITHOUT PROBLEM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273575 LOCKSCR Ø3.5 SELF-TAP L26 TAN KTT SYNTHES GMBH 2700720

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR