BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORTSCR Ø4.5 SELF-TAP L26 TI

    MDR report key: 3148681 · Received June 6, 2013

    Report

    Report Number
    8030965-2013-02704
    Event Type
    Injury
    Date Received
    June 6, 2013
    Date of Event
    May 9, 2013
    Report Date
    May 13, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    PMA / PMN Number
    K112583
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    AN ADDITIONAL EVALUATION WAS CONDUCTED BY SYNTHES (B)(4) AND THE REPORT INDICATES: THE MEASURABLE DIMENSIONS OF THE BROKEN SCREW WERE AS FAR AS POSSIBLE CHECKED AND FOUND TO BE IN COMPLIANCE WITH THE TECHNICAL DRAWINGS AND AO/ASIF SPECIFICATION. FURTHER, THE EXAMINATION OF THE RAW-MATERIAL TESTING CERTIFICATES AND 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 (ISO 5832-2). THE MICROSCOPIC VIEW OF THE BROKEN SURFACE DOES NOT SHOW ANY ANOMALIES OF MATERIALS STRUCTURE. THE WORLDWIDE COMPLAINT STATISTIC DOES NOT SHOW AN INCREASED BREAKAGE LEVEL OF THE ARTICLE IN QUESTION. MANUFACTURING AND INSPECTION RECORDS INDICATE NO PROBLEMS WITH THE LOT IN QUESTION. BASED ON THE AVAILABLE INFORMATION, THE COMPLAINT CONDITION IS LIKELY THE RESULT OF TOO STRONG MECHANICAL LOAD CAUSING THE BREAKAGE. PRODUCT CODE WAS REPORTED AS KTT. THIS IS INCORRECT AS THE APPROPRIATE PRODUCT CODE FOR THIS DEVICE SHOULD BE HWC. THE 510(K) NUMBER WAS REPORTED AS K974537. THIS IS INCORRECT AS IT SHOULD BE K112583. PLACEHOLDER.

    Description of Event or Problem · 1

    THIS IS 1 OF 1 REPORT FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: PREVIOUSLY ON AN UNKNOWN DATE, THE PATIENT WAS IMPLANTED WITH A LESS INVASIVE STABILIZATION SYSTEM (LLSS) DISTAL FEMUR FOR A PROXIMAL FEMUR FRACTURE. ON (B)(6) 2013, THE PATIENT UNDERWENT SURGERY FOR A PERI-PROSTHETIC FRACTURE. THE SURGEON DECIDED TO LEAVE THE PLATE AND DISTAL SCREWS ON AND PUT IN A BIPOLAR IMPLANT. AFTER IMPLANTING, THE SURGEON TRIED TO PUT 2 SCREWS DISTALLY INTO THE PLATE TO AVOID THE BIPOLAR END. SURGEON USED POWER TO PUT THE SCREW IN AND FINAL TIGHTENED WITH A HAND SCREWDRIVER. WHILE TIGHTENING, THE SCREW HEAD BROKE OFF. SURGEON HAD NO INTENTION OF REMOVING THE SCREW SHAFT, SO THE SCREW WAS LEFT INSIDE THE BONE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250714 CORTSCR Ø4.5 SELF-TAP L26 TI HWC SYNTHES GMBH 2702262

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention