BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRILL (STAINLESS STEEL)

    MDR report key: 8544876 · Received April 24, 2019

    Report

    Report Number
    2027467-2019-00020
    Event Type
    Injury
    Date Received
    April 24, 2019
    Date of Event
    March 26, 2019
    Report Date
    March 27, 2019
    Manufacturer
    ALPHATEC SPINE INC
    Product Code
    HTW
    UDI-DI
    00844856037113
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVALUATION BOTH RETURNED INSTRUMENT FOUND THAT MANUFACTURING LOT# 7325601 REPRESENTS THE FRACTURED INSTRUMENT. THE DETACHED SECTION WHICH REMAINS WITHIN THE PATIENTS ANTERIOR WALL OF THE L5 VERTEBRAL BODY, IS APPROXIMATELY .870" IN LENGTH AND MANUFACTURED FROM 465SS WHICH COMPLIES WITH ASTM STANDARDS. ADDITIONAL INSPECTION UNDER MAGNIFICATION FOUND THAT THE INSTRUMENT APPEARS TO HAVE FAILED DUE TO EXCESSIVE LATERAL BENDING AND NOT A TWISTING MOTION THAT WOULD BE EXPECTED WITH THE USE OF THIS DEVICE.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT TWO ASPIDA DRILLS WERE UTILIZED DURING THE CASE, ONE OF WHICH BROKE. BOTH INSTRUMENTS ARE OF THE SAME PRODUCT PART NUMBER/DESCRIPTION BUT CONTAIN A SEPARATE IDENTIFYING LOT NUMBERS. IT IS UNKNOWN WHICH MANUFACTURING LOT NUMBER BELONGS TO THE FRACTURED INSTRUMENT. LOT: 7325601, MANUFACTURED 8/21/2014; LOT: 6232206, MANUFACTURED: 3/7/2011. A REVIEW OF THE DEVICE HISTORY RECORDS FOR BOTH INSTRUMENTS REVEALED NO MANUFACTURING OR PROCESSING RELATED IRREGULARITIES. THE INSTRUMENTS WERE FOUND TO BE PROPERLY MANUFACTURED AND RELEASED IN ACCORDANCE WITH DESIGN SPECIFICATIONS. NO EVALUATION POSSIBLE AT THIS TIME. MULTIPLE ATTEMPTS TO OBTAIN THE INSTRUMENT HAVE BEEN UNSUCCESSFUL. UPON THE RECEIPT OF ADDITIONAL INFORMATION AND/OR THE PRODUCT IN QUESTION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    AN ASPIDA DRILL BIT BROKE OFF IN THE PATIENT WHILE CREATING A PILOT HOLE. THE DETACHED SECTION REMAINS POSITIONED WITHIN THE ANTERIOR WALL OF THE L5 VERTEBRAL BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336707 DRILL (STAINLESS STEEL) HTW HTW ALPHATEC SPINE INC 51907 7325601 00844856037113

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other