BEUDAMED
    FDA Adverse Event Injury Summary report: N

    316-0006

    MDR report key: 1363119 · Received April 10, 2009

    Report

    Report Number
    2027754-2009-00003
    Event Type
    Injury
    Date Received
    April 10, 2009
    Date of Event
    March 10, 2009
    Report Date
    April 10, 2009
    Manufacturer
    OSTEOMED L.P.
    Product Code
    LRN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DOCTOR SAID THIS WAS AN OSTEOMED GUIDEWIRE, HOWEVER, SALES RECORDS SHOW VERY FEW PURCHASED IN 2008 COMPARED TO NUMBER OF IMPLANTS DONE. THIS GUIDEWIRE CAME FROM THE HOSPITAL'S SET - IT WAS NOT BROUGHT IN BY TERRITORY MANAGER FOR THE CASE. LOT NUMBER INFORMATION WAS NOT PROVIDED BY HOSPITAL. THE GUIDEWIRES DISTRIBUTED BY OSTEOMED ARE PURCHASED BY OSTEOMED FROM A 3RD PARTY, WHO MANUFACTURES GUIDEWIRES FOR THE INDUSTRY. DOCTOR SPOKE TO HER CHIEF AND HE STATED THAT BROKEN GUIDEWIRES HAVE HAPPENED TO HIM BEFORE, BUT NEVER WITH OSTEOMED GUIDE WIRES. THERE IS NO RECORD OF EITHER A 316-0004 OR 316-0006 PREVIOUSLY BREAKING IN THE COMPLAINT DATABASE IN THE LAST 5 YEARS, WITH ALL THE QUANTITIES THAT HAVE BEEN SOLD. ATTEMPTS TO REPLICATE THE OBSERVED DAMAGE (TORSIONAL BREAKAGE, DAMAGED TIP) BY DRIVING THE GUIDEWIRE INTO A SCREW WERE UNSUCCESSFUL.

    Description of Event or Problem · 1

    DOCTOR PERFORMED AN AUSTIN OSTEOTOMY PROCEDURE. DOCTOR DROVE GUIDE WIRE FROM MEDIAL PROXIMAL TO DISTAL LATERAL, AND REALIZED THE WIRE HAD GONE TOO FAR INTO THE BASE. THE DOCTOR USED THE K WIRE DRIVER TO RETRACT IT BACK. WHEN IT HAD ENTERED THE HEAD OF THE 1ST METATARSAL THE DOCTOR PLACED THE SCREW. THE WIRE WAS WITHDRAWN. DOCTOR CHECKED JOINT FOR MOBILITY AND COMPLETED PROCEDURE. RADIOLOGIST CALLED DOCTOR AFTER POST-OP X-RAY TO SAY THE SCREW HAD BROKEN. DOCTOR WENT TO OBSERVE AND NOTED A PIECE OF METAL IN PROXIMAL PHALANX. SHE FELT IT WOULD NOT CAUSE PROBLEMS, HOWEVER, PATIENT COMPLAINED OF PAIN AND SWELLING. AFTER SEVERAL MONTHS DOCTOR PERFORMED CT SCAN WITH A DIFFERENT RADIOLOGIST. DETERMINED SCREW WAS FINE AND THAT METAL WAS A TIP OF THE GUIDEWIRE. FRAGMENT REMOVED IN 2009. PATIENT FINE. DURING FINAL INSERTION, THE SCREW BROKE. DOCTOR USED NEEDLE NOSE PLIERS TO REMOVE THE SCREW, DAMAGING SOME BONE IN PROCESS. DOCTOR APPLIED BONE GRAFTS AND FINISHED THE PROCEDURE USING K-WIRE. PATIENT HAS BEEN EVALUATED POST OP VIA X-RAY. EVERYTHING IS HEALING NICELY. THE PINS USED TO FIXATE IN PLACE OF THE SCREWS HAVE ALREADY BEEN REMOVED AND PATIENT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 316-0006 .045" X 6 INCH GUIDE WIRE LRN OSTEOMED L.P. 316-0006 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention