BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DHS/DCS-SCR Ø12.5 L95 SST

    MDR report key: 3133194 · Received May 29, 2013

    Report

    Report Number
    8030965-2013-02372
    Event Type
    Injury
    Date Received
    May 29, 2013
    Report Date
    April 29, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    KTT
    PMA / PMN Number
    K791619
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. AS IT IS IMPOSSIBLE TO REMOVE THE PLATE, THE RELEVANT DIMENSIONS OF THE BORE CANNOT BE MEASURED. BUT AS THE PLATE IS FREELY MOVABLE ON THE SCREW SHAFT IT IS POSSIBLE THAT NO DEVIATION OF THE BORE CAUSED THIS OCCURRENCE. THE RELEVANT DIMENSIONS OF THE SCREW WERE, AS FAR AS POSSIBLE, CHECKED AND FOUND TO BE IN COMPLIANCE WITH THE TECHNICAL DRAWINGS AND AO/ASIF SPECIFICATION. THE EXAMINATION OF THE RAW-MATERIAL TESTING CERTIFICATE AND THE MANUFACTURING PAPERS SHOWED NO DEVIATIONS REGARDING MANUFACTURING PROCESS, MATERIAL ANALYSIS, STRENGTH AND STRUCTURAL STABILITY. THE VALUES OF BOTH DEVICES WERE IN COMPLIANCE WITH AO/ASIF SPECIFICATION AND WITH THE INTERNATIONAL STANDARD ISO 5832-1. NO PRODUCT FAULT COULD BE DETECTED. WE FOUND THAT THE SLOTTED END OF THE SCREW IS DEFORMED AND THAT IT IS THEREFORE NOT POSSIBLE TO REMOVE THE PLATE. THE EXACT CAUSE OF THIS OCCURRENCE CAN NOT BE DEFINED. THERE WERE POSSIBLY FORCES APPLIED ONTO THE SLOT SHAFT FOR THE CORRECTION OF THE PLATE ORIENTATION AFTER THE PLATE WAS INSERTED ONTO THE SCREW. THIS CAN LEAD TO A DEFORMATION OF THE SCREW SLOT WHEN THE CENTERING SLEEVE IS NOT USED OR/AND WHEN THE CONNECTION SCREW IS NOT TIGHTENED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. REPORTEDLY, THE PATIENT WAS TO HAVE THE HARDWARE REMOVED AND A TOTAL HIP REPLACEMENT ON (B)(6); THE YEAR WAS UNSPECIFIED. EXPLANT DATE CANNOT BE CONFIRMED AT THIS TIME. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: PATIENT WAS IMPLANTED WITH DHS CONSTRUCT ON AN UNSPECIFIED DATE. PATIENT WAS RETURNED TO THE OPERATING ROOM ON AN UNSPECIFIED DATE FOR A PLANNED HARDWARE REMOVAL FOR A TOTAL HIP REPLACEMENT. REPORTEDLY THE DHS IMPLANT WAS REMOVED WITH GREAT DIFFICULTY AS THE PLATE WOULD NOT SLIDE OFF OF THE DHS SCREW FOR AN UNKNOWN REASON. THIS EVENT DID CAUSE A DELAY IN THE OPERATION. IT IS NOT KNOWN HOW LONG THE DHS CONSTRUCT WAS IMPLANTED FOR. THIS IS 1 OF 2 REPORTS FOR THE SAME EVENT, (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234970 DHS/DCS-SCR Ø12.5 L95 SST KTT SYNTHES GMBH 2254311

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention