BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TWIST DRILL

    MDR report key: 6404257 · Received March 14, 2017

    Report

    Report Number
    0001032347-2017-00184
    Event Type
    Malfunction
    Date Received
    March 14, 2017
    Date of Event
    January 24, 2017
    Report Date
    February 14, 2017
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HBE
    PMA / PMN Number
    PK062842
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TWO IQ 1.4 MM DRILL WITH 15 MM STOP (72-2046) WERE RETURNED WITHOUT PACKAGING. THE DRILLS WERE VISUALLY EVALUATED AND BOTH WERE FOUND TO BE IN GOOD COSMETIC CONDITION; MINOR DISCOLORATION WAS OBSERVED. THE DRILLS WERE ALSO FUNCTIONALLY INSPECTED AND WERE FOUND TO FUNCTION AS INTENDED. THE COMPLAINT FOR THE DRILLS WAS UNCONFIRMED AS BOTH PARTS SLID INTO AND OUT OF THE GAGE FREELY. IT WAS DETERMINED THAT THE MOST LIKELY UNDERLYING CAUSE OF THE COMPLAINT IS DUE TO COLLET WEAR ON THE IQ DRIVER. THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS. THIS IS REPORT TWO OF TWO FOR THE SAME EVENT. REPORT ONE OF TWO IS REPORTED ON MFR #0001032347-2017-00183-2.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING HISTORY WAS REVIEWED AND NO NON-CONFORMANCES WERE IDENTIFIED FOR THIS LOT. WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT. REPORT TWO OF TWO FOR THE SAME EVENT, REFERENCE REPORT 0001032347-2017-00183.

    Additional Manufacturer Narrative · 1

    THE DEVICE EVALUATION IS IN PROGRESS, A FOLLOW UP REPORT WILL BE SENT UPON COMPLETION OF THE DEVICE EVALUATION. REPORT TWO OF TWO FOR THE SAME EVENT, REFERENCE 0001032347-2017-00183-1.

    Description of Event or Problem · 1

    THE DISTRIBUTOR REPORTED THAT DURING A CRANIOTOMY, THE DRIVER DID NOT GET LOCKED SO THE SHAFT CAME OFF. IT IS UNKNOWN IF THE ISSUE IS WITH THE DRIVER OR THE SHAFT. NO PATIENT INJURY WAS REPORTED, HOWEVER IT IS UNKNOWN IF THERE WAS A DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186506 TWIST DRILL IQ 1.4MM DRILL W/15MM STOP HBE BIOMET MICROFIXATION N/A 663068

    Patients

    Seq Age Sex Outcome Treatment
    1