BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.3MM SQUARE SCREWDRIVER

    MDR report key: 6739467 · Received July 25, 2017

    Report

    Report Number
    0001825034-2017-05177
    Event Type
    Injury
    Date Received
    July 25, 2017
    Date of Event
    June 20, 2017
    Report Date
    March 19, 2018
    Manufacturer
    BIOMET TRAUMA
    Product Code
    HXX
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT DEVICES - CATALOG #: PEG FULLY THREADED, LOCKING 2.5MM X 10MM 131212610 LOT #: 051470, PEG FULLY THREADED, LOCKING 2.5MM X 14MM CATALOG #: 131212614 LOT #: 367030, PEG FULLY THREADED, LOCKING 2.5MM X 14MM CATALOG #: 131212614 LOT #: 863880, PEG FULLY THREADED, LOCKING 2.5MM X 16MM CATALOG #: 131212616 LOT #: 479470, PEG FULLY THREADED, LOCKING 2.5MM X 18MM CATALOG #: 131212618 LOT #: 971190, PEG FULLY THREADED, LOCKING 2.5MM X 20MM CATALOG #: 131212620 LOT #: 311690, DRILL BIT F.A.S.T. 2.0MM CATALOG #: 231201301 LOT #: 544190, CORONOID PLATE CATALOG #: 851318500 LOT #: 264300. THE CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. INSPECTION OF THE RETURNED DEVICE REVEAL THE DISTAL DRIVER TIP FRACTURED. NO TIP WAS RETURNED FOR EXAMINATION. THE DRIVER HAS TYPICAL SUPERFICIAL WEAR MARKS, CONSISTENT WITH A USED SURGICAL INSTRUMENT. THE DISTAL FRACTURE SURFACE HAS FRACTURE ARTIFACTS THAT ARE CONSISTENT WITH A ROTATIONAL SHEAR FRACTURE, WITH ALL 4 CORNERS ROUNDED. MATERIAL COMPOSITION ANALYSIS CONFIRMED THAT THE DEVICE WAS MANUFACTURED OF A MATERIAL CONFORMING TO SPECIFICATIONS. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT IS REPORTED THAT DURING A SURGICAL PROCEDURE TO TREAT A FRACTURED PROXIMAL ULNA, THE TIP OF THE SCREWDRIVER FRACTURED INSIDE THE PATIENT'S BODY. THE FRACTURED PORTION OF THE DRIVER WAS UNABLE TO BE RETRIEVED AND REMAINS IN THE PATIENT. THERE IS NO INFORMATION AVAILABLE TO CONFIRM WHETHER THE SURGEON PLANS TO REVISE OR TREAT THE PATIENT. ATTEMPTS HAVE BEEN MADE TO RETRIEVE ADDITIONAL INFORMATION, BUT NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521731 1.3MM SQUARE SCREWDRIVER SCREW, FIXATION HXX BIOMET TRAUMA N/A 158559

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| S