BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAIL

    MDR report key: 2973429 · Received February 22, 2013

    Report

    Report Number
    2520274-2013-01119
    Event Type
    Malfunction
    Date Received
    February 22, 2013
    Report Date
    January 25, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HSB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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, PG 19 AND AGAIN IN STEP 2 PG 20 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. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    A MANUFACTURING EVALUATION WAS CONDUCTED AND THE REPORT INDICATES THE NAIL WAS RECEIVED STUCK INTO PART NUMBER 03.010.435, PROTECTION SLEEVE. THE MATERIAL TIALB WAS VERIFIED WITH NITON 06 AND PASSED. AN INSPECTION OF THE PRODUCT CANNOT BE PERFORMED AND REMOVING THE PART WOULD CAUSE DAMAGE THAT WOULD BE PROHIBITIVE TO ANY INSPECTION EFFORTS. INVESTIGATION IS ON-GOING.

    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 4 OF 4 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77761 NAIL HSB SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR