BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AWL

    MDR report key: 3790667 · Received May 5, 2014

    Report

    Report Number
    1526439-2014-11489
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    April 7, 2014
    Report Date
    April 9, 2014
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    NKB
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ONE (1) HALM-ZIELKE ANTERIOR SYSTEM AWL [PRODUCT CODE: 2723-01-102, LOT NO: 20071248] WAS RETURNED TO THE COMPLAINTS HANDLING UNIT (CHU) FOR EVALUATION. VISUAL VERIFICATION REVEALED THAT THE FRACTURE WAS LOCATED AT THE AWL¿S DISTAL TIP. THE SECOND HALF OF THE TIP WAS NOT RETURNED FOR ANALYSIS. IT WAS ALSO INDICATED THAT THE SURGEON DID NOT WANT TO TAKE OUT THE BROKEN TIP AS IT REMAINS IN THE VERTEBRAE OF THE PATIENT. A SCANNING ELECTRON MICROSCOPY (SEM) ANALYSIS WAS PERFORMED ON THE FRACTURED SURFACE TO FACILITATE A MORE DETAILED INVESTIGATION OF THE FRACTURE CHARACTERISTICS OF THE PART. RESULTS SHOW EVIDENCE OF A QUASI-STATIC TORSIONAL SHEAR FAILURE. NO MATERIAL DEFECTS OR OTHER ABNORMALITIES WERE OBSERVED IN THIS ANALYSIS. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THE HALM-ZIELKE ANTERIOR SYSTEM AWL WAS CONDUCTED. NO DISCREPANCIES WERE OBSERVED DURING THE MANUFACTURING PROCESS. THE PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY REQUIREMENTS. A 12-MONTH REVIEW OF THE COMPLAINT TREND ANALYSIS FOR THE HALM-ZIELKE ANTERIOR SYSTEM AWL WAS CONDUCTED ON THE SPECIFIC PRODUCT CODE FROM THIS COMPLAINT FILE AS THE PRODUCT FAMILY DOES NOT EXIST FOR THIS INSTRUMENT. IT WAS NOTED THAT THERE WERE NO OTHER REPORTED COMPLAINTS OTHER THAN THIS ONE FOR ISSUES ASSOCIATED WITH THE AWL¿S DISTAL TIP BECOMING FRACTURED. THE ROOT CAUSE OF THE HALM-ZIELKE ANTERIOR SYSTEM AWL DISTAL TIP BECOMING FRACTURED CANNOT POSITIVELY BE DETERMINED. HOWEVER, THE SEM RESULTS SHOW EVIDENCE OF A QUASI-STATIC TORSIONAL SHEAR FAILURE. AS NO ISSUES HAVE BEEN IDENTIFIED IN THE MANUFACTURING OR RELEASE OF THIS INSTRUMENT NOR HAVE ANY SYSTEMATIC TRENDS BEEN IDENTIFIED, THIS COMPLAINT FILE WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED.

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE REPORTS THE SURGEON HAD DIFFICULTY REMOVING THE AWL FROM THE VERTEBRAE AND BEGAN TO TURN THE AWL SEVERAL TIMES. AFTER SOME TRIES, HE WAS ABLE TO PULL THE AWL OUT OF THE PATIENT. THEN HE SAW THAT THE FRONT TIP OF THE AWL WAS BROKEN AND APPROXIMATELY 3CM OF THE AWL IS NOW IN THE VERTEBRAE OF THE PATIENT. THERE WAS NO SALES REPRESENTATIVE PRESENT IN THE OPERATING ROOM DURING THE PROCEDURE. THE SURGEON DOES NOT WANT TO REMOVE THE BROKEN PORTION OF THE AWL BY NOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268725 AWL AWL NKB DEPUY SYNTHES SPINE 20071248

    Patients

    Seq Age Sex Outcome Treatment
    1