BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    12.0MM PROTECTION SLV STRAIGHTFOR 8MM-11MM NAILS

    MDR report key: 2973877 · Received February 22, 2013

    Report

    Report Number
    1719045-2013-00400
    Event Type
    Malfunction
    Date Received
    February 22, 2013
    Report Date
    January 25, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    JDS
    PMA / PMN Number
    K111667
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD REVIEW WAS CONDUCTED. AVALIGN TECHNOLOGIES - NEMCOMED MANUFACTURED THE 12.0MM PROTECTION SLEEVE STRAIGHT FOR 8MM-11MM NAILS, P/N 03.010.435, LOT NUMBER 6493641. THE LOT WAS MADE PER PO NUMBER 1199641, DATED APRIL 15, 2011, LINE 3, FOR 65 PARTS. THE CERTIFICATE OF COMPLIANCE, DATED APRIL 14, 2011, INDICATED THE PARTS MET SPECIFICATIONS. THE LOT WAS INSPECTED TO THE SYNTHES INCOMING FINAL INSPECTION SHEET NUMBER NS043192, REVISION E. NCR NUMBER US1049199 WAS WRITTEN ON APRIL 22, 2011, FOR 6 PARTS OUT OF 65 IN THE LOT, NOT ACCEPTING NO/GO-GAGE,12.200 TO 12.243MM DIMENSION. FIVE PARTS WERE DISPOSITIONED AS USE-AS-IS, UAI PER THE SYNTHES PRODUCT DEVELOPMENT ENGINEER, PDE, AND 1 PART WAS SCRAPPED FOR PDE EVALUATION. THE NCR WAS CLOSED ON APRIL 26, 2011. NCR NUMBER U.S. 1049196 WAS WRITTEN ON A FIRST ARTICLE INSPECTION, FAI, LOT, ON APRIL 21, 2011 FOR THE 17.457 MM TO 17.500 MM DIAMETER NONCONFORMING TO 17.512 MM, FOR THE COMPONENT P/N 03.010.435.1. ONE PART FAILED OUT OF THE THREE FAI PARTS. THE NCR WAS DISPOSITIONED AS UAI PER THE SYNTHES PDE AND THE NCR WAS CLOSED ON APRIL 22, 2011. A MANUFACTURING EVALUATION WAS CONDUCTED. DUE TO AN UNKNOWN CAUSE, THE NAIL BECAME STUCK INSIDE THE PROTECTION SLEEVE, CAUSING THE SLEEVE TO BECOME DISTORTED. THERE ARE SOME MINOR SCUFFMARKS ON THE PART. BASED ON THE EVALUATION AND THE UNKNOWN CAUSE, A CONCLUSION CANNOT BE DETERMINED, FROM A MANUFACTURING POSITION. A PRODUCT DEVELOPMENT EVENT EVALUATION WAS CONDUCTED. THE DESCRIPTION OF "STUCK" IS ACCURATE. NO COLD-WELDING OCCURRED. RISK ANALYSIS ADEQUATELY ADDRESSES THE COMPLAINT. THE PRIMARY BENEFIT OF THE SUPRAPATELLAR SYSTEM IS THAT IT HAS A FLEXIBLE OUTER PROTECTION SLEEVE TO PROTECT THE PATIENT DURING INSERTION OF A BENT NAIL AND A RIGID INNER PROTECTION SLEEVE TO PROTECT THE FLEXIBLE OUTER PROTECTION SLEEVE FROM ROTATING SHARP DEVICES LIKE DRILLS AND REAMERS. THE RIGID SLEEVE IS NOT INTENDED TO PASS THE BENT NAIL AS THE NAIL WILL NOT FIT. THIS IS ADDRESSED IN STEP 1, AND AGAIN IN STEP 2 OF THE SUPRAPATELLAR TECHNIQUE GUIDE: J10459-B. FAILURE WAS CAUSED BY FORESEEABLE INAPPROPRIATE USE AND NOT DESIGN. ALL REASONABLE DESIGN PRECAUTIONS HAVE BEEN TAKEN.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM.

    Description of Event or Problem · 1

    THIS IS 1 OF 4 REPORTS FOR THE SAME EVENT, COMPLAINT (B)(4).

    Description of Event or Problem · 1

    IM NAILING OF A PROXIMAL ONE THIRD TIBIAL SHAFT FRACTURE, DATE OF FRACTURE UNKNOWN: THE CASE WAS GOING FINE BUT THE INITIAL NAIL THAT WAS INSERTED WAS TOO SHORT. WHEN THE SURGEON TOOK THE NAIL OUT TO PUT A NEW ONE IN, THE NAIL GOT STUCK IN THE INSTRUMENT. THE DRIVING CAP BROKE OFF INSIDE THE INSERTION HANDLE AND THE NAIL GOT COLD WELDED ONTO THE SLEEVE. NO ADVERSE EFFECT TO THE PATIENT WAS NOTED. THIS IS 1 OF 4 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78254 12.0MM PROTECTION SLV STRAIGHTFOR 8MM-11MM NAILS PROTECTION SLV STRAIGHT JDS SYNTHES MONUMENT 6493641

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR