BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.5MM VA-LCP CURVED CONDYLAR PLATE/14 HOLE/301MM/RIGHT

    MDR report key: 3221049 · Received July 11, 2013

    Report

    Report Number
    8030965-2013-04278
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Date of Event
    June 14, 2013
    Report Date
    June 14, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    JDP
    PMA / PMN Number
    K110354
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL CLASSIFICATION CODES HRS, HWC. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    USER FACILITY REPORTED THE PATIENTS AGE AT THE TIME OF EVENT TO BE (B)(6). CORRECTION: THE PATIENT'S AGE IS (B)(6) AT THE TIME EVENT. CORRECTION: THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Additional Manufacturer Narrative · 1

    A MANUFACTURING EVALUATION WAS CONDUCTED. THE REPORT INDICATES TWO OF THE THREE AIMING ARM POSITIONING BORES HAVE A STRONG NICK ON ONE SIDE AND A BURR ON TOP. THE THREAD FLANKS OF THE LOCKING THREAD, WHICH IS USED TO FIX THE AIMING ARM, ARE ALSO PARTIALLY STRIPPED. THE RELEVANT DIMENSIONS CANNOT BE VERIFIED ANYMORE BECAUSE OF THE DESCRIBED DAMAGES. HOWEVER, IT IS CLEARLY VISIBLE THAT THESE NICKS WERE CAUSED POST MANUFACTURING AS THE ANODIZATION LAYER IS WORN OUT THERE. THAT THE DAMAGES ARE ONLY IN ONE DIRECTION AND ONLY AT TWO OF THE THREE POSITIONING BORES INDICATES THAT AIMING ARM WAS STRONGLY PUSHED SIDEWARD, WHILE THE BIGGER, INTACT, BORE WAS THE CENTER OF THE MOVEMENT THE OTHER TWO BORES DID GET DAMAGED. THIS IS INDICATIVE OF THE AIMING ARM WAS NOT PROPERLY FIXED ON THE PLATE, SUCH A LOOSE CONNECTION WOULD ALSO EXPLAIN THE DAMAGE OF THE LOCKING THREAD, WHERE THE AIMING ARM IS FIXED. A PRODUCT DEVELOPMENT EVALUATION WAS ALSO CONDUCTED. THE REPORT INDICATES THE THREE LOCATION DIMPLES USED TO LOCATE AND SECURE THE INSERTION HANDLE AND AIMING ARM ARE DAMAGED. THE TWO PROXIMAL DIMPLES CLEARLY SHOW DISPLACED MATERIAL. (B)(4). THE RISK ANALYSIS INCLUDES THE HAZARD OF THE INSERTION HANDLE NOT FITTING PROPERLY WITH THE PLATE DIMPLES. THE COMPLAINT DESCRIPTION INDICATES THAT THE AIMING ARM WAS NOT PROPERLY TIGHTENED DOWN WITH THE WRENCH. THE DAMAGED DIMPLES ON THE PLATE ARE CONSISTENT WITH EXCESSIVE TORQUE APPLICATION WITH THE INSERTION HANDLE NOT PROPERLY TIGHTENED. THIS COULD ALSO LEAD TO DISENGAGEMENT OF THE AIMING ARM FROM THE PLATE AS OCCURRED IN THIS CASE. CONSIDERING THE LOW RATE OF OCCURRENCE AND THE FACT THAT THE INSERTION HANDLE WAS NOT PROPERLY SECURED TO THE PLATE, IT IS UNLIKELY THE DESIGN PLAYED A SIGNIFICANT ROLE IN THIS FAILURE. THE DESIGN RISK ASSESSMENT ADEQUATELY ADDRESSES THE COMPLAINT EVENT.

    Description of Event or Problem · 1

    USER FACILITY MEDWATCH# (B)(4) WAS RECEIVED. A COPY OF THE USER FACILITY REPORT WILL BE INCLUDED IN THIS REPORT. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    SURGEON WAS ADJUSTING THE 4.5 MM VARIABLE ANGLE (VA) LOCKING COMPRESSION PLATE (LCP) WITH THE AIMING ARM ANTERIORLY AND POSTERIORLY THE OUTRIGGER POPPED OFF THE ATTACHMENT. WHEN THE SURGEON PULLED OUT THE PLATE, THERE WERE 3 INDENTS ON THE PLATE WHERE THE OUTRIGGER POST WOULD GO AND THREAD INTO THE LOCKING VA HOLE. THERE ARE NOW TRACKS WHERE THE PLATE HAD SLID AND WOULD NOT ALIGN. A NEW PLATE HAD TO BE USED. AFTER THE POSITION THE RA MENTIONED HE DID NOT SECURE THE AIMING ARM WITH A WRENCH AS PRESCRIBED, WHICH ALLOWS ROOM FOR THE PLATE TO TOGGLE. SURGERY WAS DELAYED 15 MINUTES AS A RESULT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319707 4.5MM VA-LCP CURVED CONDYLAR PLATE/14 HOLE/301MM/RIGHT JDP SYNTHES GMBH 8346613

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR