BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCP DISTTIBPL2.7/3.5 MED R SHAFT 8HO TI

    MDR report key: 3041831 · Received April 8, 2013

    Report

    Report Number
    8030965-2013-01457
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    February 1, 2013
    Report Date
    March 12, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    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. 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. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA.

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE COMPLAINED LCP DISTTIB PLATE WAS SENT TO OUR PRODUCT DEVELOPMENT ENGINEER FOR INVESTIGATION; THE FEEDBACK IS: THE LCP SCREW CANNOT BE REMOVED WITH A STANDARD SCREWDRIVER. THERE IS A POSSIBILITY OF COLD WELDING OF SCREW TO THE PLATE. FURTHER, THIS COMPLAINT GOT SENT TO THE INTERNAL TESTING DEPARTMENT FOR INVESTIGATION AND TESTING; HERE THE FEEDBACK: THE STAR DRIVE OF THE PROVIDED LOCKING SCREW IS COMPLETELY WORN OUT. WITH A PROVIDED FUNCTIONAL TEST, THE TORQUE THAT WAS NEEDED TO UNSCREW THE SCREW OUT OF THE PLATE WAS MEASURED. BY 4.35NM OF TORQUE THE SCREW SHAFT UNFORTUNATELY BROKE OFF. THE ARTICLE WAS ANALYZED FOR CONFORMANCE TO PRINT SPECIFICATION, AS WELL AS THE DEVICE HISTORY RECORD WAS RESEARCHED. NO ABNORMAL FINDINGS WERE IDENTIFIED. NO PRODUCT FAULT COULD BE DETECTED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: PATIENT WAS IMPLANTED WITH PLATE AND SCREW CONSTRUCT DURING A DISTAL TIBIAL OSTEOTOMY ON AN UNKNOWN DATE. ON (B)(6) 2012 PATIENT WAS DIAGNOSED WITH DISEASE, AND ALL HARDWARE HAD TO BE REMOVED. ON (B)(6) 2013, DURING THE REMOVAL PROCEDURE, SURGEON HAD A DIFFICULT TIME REMOVING ONE SCREW. HE WAS FORCED TO TURN THE PLATE LIKE A PROPELLER IN ORDER TO REMOVE THE SCREW. IT WAS REPORTED THAT PATIENT HAD POOR BONE QUALITY. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THIS IS 1 OF 2 REPORTS FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143791 LCP DISTTIBPL2.7/3.5 MED R SHAFT 8HO TI HRS SYNTHES GMBH 3708087

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention