BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESORBABLE SLEEVE FOR 5.00 MM

    MDR report key: 2945271 · Received February 1, 2013

    Report

    Report Number
    8030965-2013-10040
    Event Type
    Malfunction
    Date Received
    February 1, 2013
    Date of Event
    March 15, 2011
    Report Date
    March 15, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HSB
    PMA / PMN Number
    K090241
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED (B)(4) 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF SYNTHES DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ASLS SYSTEM TIBIA EX NAIL PROCEDURE, THE SURGEON INSERTED TWO RESORBABLE SLEEVES OVER THE TWO 5.00 MM TI ANGULAR STABLE LOCKING SCREWS. AS THE SURGEON STARTED TO IMPACT GENTLY TO INSERT INTO NAIL, THE TWO SCREWS WOULD NOT ADVANCE WITH GENTLE TAPPING. THE SURGEON USED A DRIVER AND IMPACTED WITH SOME FORCE TO SEAT THE SCREWS. ALL PRODUCTS WERE IMPLANTED; HOWEVER, THE PROCEDURE WAS EXTENDED 15-20 MINUTES. THIS IS DEVICE 3 OF 3 FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43751 RESORBABLE SLEEVE FOR 5.00 MM HSB SYNTHES GMBH 2566903

    Patients

    Seq Age Sex Outcome Treatment
    1 5.00 MM TI ANGULAR STABLE LOCKING SCREWS X2