BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.7MM THRDD STEPPED SCR 20MM F/OLECRANON OSTEOTOMY NL-STER

    MDR report key: 3000777 · Received March 12, 2013

    Report

    Report Number
    8030965-2013-10454
    Event Type
    Injury
    Date Received
    March 12, 2013
    Report Date
    June 21, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HSB
    PMA / PMN Number
    K073402
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    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 FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING DISTAL HUMERUS FRACTURE W/ OLECRANON OSTEOTOMY PROCEDURE, OLECRANON NAIL WAS USED FOR OSTEOTOMY. WHEN PUTTING IN THE NAIL, THE DISTAL STABILIZATION K-WIRE, WHICH GOES OUT SIDE OF THE NAIL THROUGH THE AIMING ARM, SKIVED OFF THE ULNA AND TORQUED THE AIMING ARM CAUSING THE SURGEON TO DRILL OUTSIDE OF THE NAIL FOR THE LOCKING SCREW HOLE. WHEN THEY NOTICED WHAT HAD HAPPENED, THEY REPOSITIONED THE K-WIRE AND REDRILLED THE HOLES, AND REINSERTED THE SCREWS. THE NAIL WAS LARGE FOR HER CANAL. THE ULNA FRACTURED AT THE TIP OF THE NAIL, STARTING AROUND THE OPEN HOLE THAT WE DRILLED. IT APPEARS TO BE A COMBINATION OF A RISE IN STRESS IN AN OPEN HOLE, END OF AN IMPLANT, AND A LARGE IMPLANT IN A SMALL BONE. THIS IS 2 OF 3 REPORTS FOR THE SAME EVENT.

    Description of Event or Problem · 1

    THIS IS REPORT 3 OF 3 FOR THIS COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103731 2.7MM THRDD STEPPED SCR 20MM F/OLECRANON OSTEOTOMY NL-STER HSB SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention