BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.4MM TI VA-LCP 2-CLMN VLR DSTRAD PL 6H HD/4H SHAFT/RT-STER

    MDR report key: 3181728 · Received June 21, 2013

    Report

    Report Number
    8030965-2013-03738
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    May 20, 2011
    Report Date
    August 19, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    PMA / PMN Number
    K083694
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. THE DEVICE LISTED IN THIS REPORT IS USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. THE DEVICE WAS RETURNED FOR INSPECTION AND THE EVENT WAS CONFIRMED. THE INVESTIGATION OF THE LOCKING SCREWS SHOWS THAT TWO BURRS CAME OFF THE SCREW DURING THE REMOVAL PROCEDURE. IT IS OBVIOUS THAT THE SCREWS CAME INTO HARD CONTACT WITH THE PLATE DURING THE REMOVAL PROCEDURE AND THE THREADS WERE SHEARED OFF WHILE IN STRONG CONTACT WITH THE PLATE. A REVIEW OF THE DHR INDICATES THERE WERE NO ANOMALIES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THIS COMPLAINT. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. ALL RECORDS INDICATE THE PRODUCT WAS MANUFACTURED TO SPECIFICATIONS. NO PRODUCT FAULT COULD BE DETECTED. CONCLUSION: THE COMPLAINT IS CONSIDERED INDETERMINATE FROM A MANUFACTURING PERSPECTIVE AS NO PRODUCT FAULT COULD BE DETECTED. AS THE SCREW THREADS WERE SHEARED OFF WHILE IN STRONG CONTACT WITH THE PLATE DURING THE REMOVAL PROCEDURE, THIS DEVICE FAILURE IS RELATED TO THE CONDITIONS OF USE AND OPERATIONAL CONTEXT CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO BURRS CAME OFF THE SCREW DURING THE REMOVAL PROCEDURE. THE PATIENT FELT PAIN ON THE FLEXOR TENDON AND THEN THE DOCTOR REMOVED THE VA LOCKING SCREW DISTAL. AT THAT TIME TWO BURRS CAME OUT OF THE SCREW HEAD. THEY LOOK SPRING SHAPE AND PROBABLY THE THREAD WAS PEELED. THE DOCTOR FOUND THE BURR IN THE PATIENT BODY AFTER THE SCREW WAS REMOVED. HE THINKS THAT THE BIG LOAD APPLIED ON THE SCREW HEAD MAKES A BURR. NO FURTHER INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283264 2.4MM TI VA-LCP 2-CLMN VLR DSTRAD PL 6H HD/4H SHAFT/RT-STER HRS SYNTHES GMBH 3310678

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention