BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIV-FEMNAIL Ø10 L360 SST

    MDR report key: 2912056 · Received January 11, 2013

    Report

    Report Number
    8030965-2013-00113
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    November 17, 2012
    Report Date
    December 14, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HSB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE MEASURABLE DIMENSIONS WERE FOUND TO BE IN COMPLIANCE WITH THE TECHNICAL DRAWINGS AND ARE WITHIN SPECIFICATION. THE EXAMINATION OF THE RAW MATERIAL TESTING CERTIFICATE AND THE MANUFACTURING PAPERS SHOWED NO DEVIATIONS REGARDING MATERIAL ANALYSIS, STRENGTH AND STRUCTURAL STABILITY. THE VALUES WERE IN COMPLIANCE WITH AO ASIF SPECIFICATION AND WITH THE INTERNATIONAL STANDARD. WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE OF THIS OCCURRENCE, AS NO FURTHER DETAILED INFORMATION WAS AVAILABLE. WE DO SUPPOSE THOUGH THAT A MECHANICAL OVERLOAD DURING USE CAUSED THE DEFORMATION OF THE SCREW. NO PRODUCT RELATED CONDITION WAS FOUND.

    Additional Manufacturer Narrative · 1

    DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(4) AS FOLLOWS: DURING A PROCEDURE, THE NAIL BECAME BENT. IT WAS REPORTED THE DRILL BIT GUIDE WAS PASSED AND REAMING OF THE MEDULLARY CANAL WAS STARTED WITH 8.5MM DRILL AND THEN TO 11MM DRILL TO PLACE THE NAIL. THE NAIL WAS INSERTED MANUALLY AND THEN WAS HIT WITH THE MALLET UNTIL IT STOP AND THE INSERTION HANDLE IS ROTATED ANTERIORLY. THE SURGEON DECIDED TO BACK OUT THE NAIL A BIT. UNDER THE IMAGE INTENSIFIER, IT WAS NOTED THAT THE TIP OF THE NAIL IS AT THE BEGINNING OF THE FRACTURE. REPORTEDLY THE NAIL POINT WAS BENT ANTERIORLY AT THE DISTAL LOCK REGION. IT WAS THEN ENTERED BY THE KEY ROD IN THE LOCKING HOLE MORE PROXIMAL AND STRAIGHTENING WAS ATTEMPTED. THE MOUNTING WAS REVIEWED. THE NAIL WAS RE-ENTERED THROUGH THE GUIDE INTO THE MEDULLARY CAVITY. THE NAIL WAS ADVANCED MANUALLY AND IMPACTED WITH A MALLET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16863 UNIV-FEMNAIL Ø10 L360 SST UNIV-FEMNAIL HSB SYNTHES GMBH 2777317

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR