BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7.3MM CANNULATED LOCKING SCREW110MM

    MDR report key: 3072254 · Received April 23, 2013

    Report

    Report Number
    1719045-2013-10843
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Report Date
    October 18, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    JDW
    PMA / PMN Number
    K040765
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE MANUFACTURING EVALUATION, VISUAL INSPECTION REPORT STATES THAT ONE PIECE WAS RETURNED FOR EVALUATION. THERE IS EXTENSIVE THREAD DAMAGE THE ENTIRE LENGTH OF THE SCREW. SINCE RELEVANT FEATURES COULD NOT BE CHECKED DUE TO EXTENSIVE DAMAGE AND THERE WERE NO ISSUES WERE FOUND IN DHR REVIEW THIS COMPLAINT IS INDETERMINATE FROM A MANUFACTURING STANDPOINT.

    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. PRODUCT DEVELOPMENT EVALUATION FOUND PRODUCT RECEIVED SEVERELY DAMAGED AND IN A CONDITION SIMILAR TO COMPLAINT DESCRIPTION. HOWEVER, THE COMPLAINT COULD NOT BE REPLICATED WITH THE RETURNED DEVICE. THE MAJOR DIAMETER OF THE SCREW IS INTENDED TO BE 7.3 MM FOR THE ENTIRE LENGTH OF THE SCREW BUT MEASURED BETWEEN 6.64 AND 6.75 FOR MOST OF THE LENGTH (USING CALIPERS CA814) UPON RETURN. THE FINAL 6 THREADS (OUT OF 49 FULL THREADS) APPEARED UNDAMAGED AND MEASURE CORRECTLY AT 7.3 MM. THE CROWNS OF THE OTHER THREADS WERE MASHED/FLATTENED AND MOST OF THEM HAD GROOVE CUT INTO THE TOP OF THEM. THE SCREW APPEARED TO HAVE BEEN INSERTED INTO A THREADED HOLE THAT WAS TOO SMALL FOR THE SCREW AND DAMAGED THE THREADS OVER THE LENGTH THAT INSERTION WAS ATTEMPTED. THE HEX RECESS IN THE TOP OF THE SCREW WAS SEVERELY DAMAGED AND THE FLATS ON EITHER SIDE OF EACH POINT WAS DAMAGED AND BURRS HAD BEEN RAISED. THIS IS CONSISTENT WITH EXCESSIVE INSERTION AND REMOVAL TORQUE BEING APPLIED TO THE RECESS WHICH WOULD BE CONSISTENT WITH THE SCREW BINDING IN A PLATE HOLE THAT WAS NOT ADEQUATELY SIZED FOR THIS SCREW AND BECOMING STUCK AND THEN EXCESSIVE FORCE BEING REQUIRED TO REMOVE IT. THE SLIVERS OF METAL NOTED WERE DUE TO THE METAL BEING DISPLACED AS A RESULT. THE SELF-DRILLING TIPS WERE DAMAGED AS WELL AND THE ONE REMAINING TIP HAD A GROOVE CUT INTO IT AND SEVERAL OTHER GOUGES AND CUTS. THE CAUSE OF THE COMPLAINT CONDITION APPEARS TO BE FROM THE USER TRYING TO INSERT THE SCREW INTO A PLATE HOLE THAT IS TOO SMALL TO ACCEPT THE 7.3 MM CANNULATED LOCKING SCREW. THIS SCREW IS INTENDED FOR USE WITH THE LCP CONDYLAR PLATES, THE PROXIMAL FEMUR PLATES AND PROXIMAL FEMUR HOOK PLATES AND THE SMALLEST ID OF THE MATING HOLES IN THOSE PLATES IS 7.63 MM. THEREFORE, BY DESIGN, THERE IS CLEARANCE FOR THE THREADED SHAFT OF THE SCREW AND THERE SHOULD NOT BE CONTACT CAUSED BY THE SCREW PASSING THROUGH THE PLATE. THE DESIGN HAS BEEN EVALUATED AND IS ADEQUATE FOR THE INTENDED USE AND THEREFORE THE COMPLAINT IS INVALID FROM A DESIGN STANDPOINT. THE COMPLAINT CONDITION WAS CAUSED BY THE USER ATTEMPTING TO INSERT THE 7.3 MM SCREW INTO A PLATE HOLE THAT WAS NOT LARGE ENOUGH TO ACCEPT TO THE SCREW. ORIGINAL DATE AWARE IS BEING CORRECTED TO (B)(46 2013. ADDITIONAL INFORMATION RECEIVED ON 08/14/2013.

    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. ORIGINAL AWARENESS DATE IS 10/18/2012.

    Description of Event or Problem · 1

    SYNTHES (B)(6) TRAUMA PRODUCT MANAGER REPORTED THAT SCREW THREADS ARE PEELING BUT ARE STILL ATTACHED TO SCREW. ONE PEELING THREAD WAS ORIGINALLY ATTACHED BUT BROKE OFF WHEN PACKAGE WAS OPENED. THE INFORMATION PROVIDED DOES NOT SUGGEST COMPLAINED PRODUCT WAS USED IN A PROCEDURE, OR THAT THERE WAS ANY HARM TO A PATIENT. EVENT #1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174946 7.3MM CANNULATED LOCKING SCREW110MM JDW SYNTHES MONUMENT 6143638

    Patients

    Seq Age Sex Outcome Treatment
    1