BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DHS/DCS-SCR Ø12.5 L95 SST

    MDR report key: 2826580 · Received November 9, 2012

    Report

    Report Number
    8030965-2012-01218
    Event Type
    Injury
    Date Received
    November 9, 2012
    Report Date
    October 11, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    KTT
    PMA / PMN Number
    K791619
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT. ADDITIONAL NARRATIVE: INVESTIGATION COORDINATED BY SYNTHES (B)(4). REPORT RECEIVED INDICATES THE MEASURABLE DIMENSIONS OF THE WRENCH AND DHS/DCS 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 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. THE FRACTURE FACE AT THE WRENCH IS HOMOGENOUS, WHICH INDICATES MATERIAL CONFORMITY. VISUAL INSPECTIONS NOTED THE FIRST THREE FLANKS OF THE DHS/DCS SCREW ARE FLATTENED. IT IS POSSIBLE THE SCREW CAME IN CONTACT WITH AN ANTEVERSION WIRE AND A MECHANICAL OVERLOAD BY AN EXCESSIVE METALLIC CONTACT DURING INSERTION CAUSED THE BREAKAGE OF THE WRENCH. NO PRODUCT FAULT COULD BE DETECTED. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. CORRECTED DATA: LOT #: CORRECTED LOT NUMBER FROM 781730 TO 7815730.

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS ON-GOING. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. NO CONCLUSION CAN BE DRAWN. REVIEW OF MANUFACTURING RECORDS HAS BEEN REQUESTED. NOTE: BLANK FIELDS ON THIS FORM INDICATE INFORMATION THAT IS UNKNOWN, UNAVAILABLE OR UNCHANGED. DEVICE WAS USED FOR TREATMENT. PLACEHOLDER.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT DURING AN EMERGENCY PROCEDURE ON A BASIC CERVICAL FRACTURE, WHEN THE SURGEON WAS ATTEMPTING TO INSERT A DHS/DCS SCREW THE WRENCH BROKE. THE SURGEON REMOVED THE SCREW AND USED A COMPETITORS SCREW AND PLATE TO COMPLETE THE PROCEDURE. THE SURGEON HAD DIFFICULTY REMOVING THE DHS/DCS SCREW WHICH LEAD TO A SIGNIFICANT PROLONGATION OF THE PROCEDURE. THIS REPORT IS #2 OF 2 FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DHS/DCS-SCR Ø12.5 L95 SST DHS/DCS-SCR Ø12.5 L95 SST KTT SYNTHES GMBH 7815730

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention WRENCH