BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONNECSCR F/INSERTION DHS BLADE

    MDR report key: 3050830 · Received April 10, 2013

    Report

    Report Number
    8030965-2013-01565
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    February 18, 2013
    Report Date
    March 14, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRESENT CONNECTING SCREW FOR INSERTION OF DHS BLADE BROKE AT THE WELDED AREAS. THE MACROSCOPIC ASSESSMENT OF THE BROKEN PART REVEALED SLIGHTLY DISCOLORATIONS ON THE BOTH PART ELOSE TO THE FRACTURE AREAS AND AT THE FRACTURE AREA. DAMAGED AREAS COULD BE DOCUMENTED AT ALL THE FRACTURE SURFACES. THE EXAMINATION BY SCANNING ELECTRON MICROSCOPE (SEM) REVEALED AT THE ENTIRE FRACTURE SURFACE DAMAGED AREAS AND RESIDUES OR CORRODED AREAS AT BOTH FRACTURED PARTS. THE FRACTURE MECHANISM COULD BE NOT DETERMINED THE STRUCTURE OF THE FRACTURE SURFACE WERE NOT VISIBLE OR DAMAGED. THE MICROSTRUCTURE OF THE WELDED AREA WAS EXEMPT OF PORE OR CAPILLARY CRACKS. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. 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)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING A PROCEDURE ON (B)(6) 2013, IT WAS REPORTED THE CONNECTION SCREW FELL APART. AFTER THE SURGEON INSERTED THE BLADE PER THE GLOBAL TECHNIQUE GUIDE, HE REMOVED THE CONNECTING SCREW FROM THE BLADE. REPORTEDLY THE COUPLING SCREW WAS BROKEN IN THE SHAFT PART AND THEREFORE A PART OF THE SHAFT WAS REMOVED. THE SURGEON REMOVED THE REMAINDER OF THE DEVICE ALONG WITH THE BLADE. THE SURGEON THEN INSERTED THE BLADE WITHOUT A CONNECTING SCREW AND COMPLETED THE SURGERY. THIS IS 1 OF 1 REPORT FOR COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149897 CONNECSCR F/INSERTION DHS BLADE LXH SYNTHES GMBH 2260851

    Patients

    Seq Age Sex Outcome Treatment
    1