BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIP SCR Ø6.5 SELF-TAP L75 F/EXPERT LFN T

    MDR report key: 2822677 · Received November 7, 2012

    Report

    Report Number
    8030965-2012-01207
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Date of Event
    September 10, 2012
    Report Date
    October 9, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HSB
    PMA / PMN Number
    K040336
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 1

    AN INTERNAL INVESTIGATION WAS PERFORMED AT SYNTHES (B)(4). FUNCTIONAL TESTING OF THE COMPLAINED HIP SCREW CONFIRMS THAT THIS ARTICLE DOES CORRESPOND FULLY TO OUR SPECIFICATIONS. THE SCREW WAS ANALYZED FOR CONFORMANCE TO PRINT SPECIFICATIONS AS WELL AS THE DEVICE HISTORY RECORD WAS RESEARCHED; NO ABNORMAL FINDINGS WERE IDENTIFIED. MANUFACTURING AND INSPECTION RECORDS INDICATED NO PROBLEMS WITH THE LOT IN QUESTION. NO VALID SIMILAR ISSUE HAS OCCURRED IN THE PAST.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM (B)(4) INDICATED A HOSPITAL AND-OR SURGEON REPORTED: PATIENT EXPERIENCED A FRACTURE OF THE FEMORAL SHAFT AND DURING THE PROCEDURE: SURGEON WAS INSERTING THE HIP SCREW ACCORDING TO THE TECHNIQUE GUIDE WITH THE T-25 SCREWDRIVER. AS SURGEON WENT TO DETACH THE HIP SCREW FROM THE DRIVER IT WOULD NOT DETACH AND THE HIP SCREW WAS PULLED OUT WITH THE DRIVER. AFTER SOME MANIPULATION, SURGEON MANAGED TO REMOVE THE HIP SCREW FROM THE DRIVER. ANOTHER SCREW WAS SELECTED AND INSERTED, THE PROCEDURE WAS COMPLETED. THIS IS 1 OF 2 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HIP SCR Ø6.5 SELF-TAP L75 F/EXPERT LFN T HIP SCREW HSB SYNTHES GMBH 7670868

    Patients

    Seq Age Sex Outcome Treatment
    1 HIP SCREW, T-25 SCREWDRIVER