BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAINLESS STEEL K-WIRE 1.6MM

    MDR report key: 6659515 · Received June 22, 2017

    Report

    Report Number
    0001825034-2017-04193
    Event Type
    Malfunction
    Date Received
    June 22, 2017
    Date of Event
    May 16, 2017
    Report Date
    May 4, 2018
    Manufacturer
    BIOMET TRAUMA
    Product Code
    HTY
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LOT# 994080, 994070, 994060, 994050, 994040, 994030, 994020, 994010, 993970, 993980, 958440, 958400, 958390, 958380, OR 958370. UDI NUMBERS: ((B)(4). COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. AS NOTED IN THE ATTACHED REPORT MICROSCOPY AND MATERIAL ANALYSIS REPORT (B)(4), THE RETURNED PLATE HAS MINOR COSMETIC DAMAGE, AND A PIECE OF THE FRACTURED K-WIRE STUCK IN IT, BUT IS OTHERWISE UNDAMAGED. SCANNING ELECTRON MICROSCOPY (SEM ANALYSIS) CONDUCTED ON THE K-WIRE IDENTIFIED FRACTURE ARTIFACTS CONSISTENT WITH DUCTILE OVERLOAD. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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.

    Additional Manufacturer Narrative · 1

    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.

    Additional Manufacturer Narrative · 1

    (B)(6). 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. (B)(4). CONCOMITANT DEVICES: DVR ANATOMIC SHORT PLATE WITH F.A.S.T GUIDE INSERTS, CATALOG #: 131212006, LOT #: 392700. THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME PATIENT ((B)(4)).

    Description of Event or Problem · 1

    IT IS REPORTED THAT THAT DURING A DISTAL RADIUS FRACTURE TRAUMA PLATING PROCEDURE, THE K-WIRE FRACTURED WHEN THE SURGEON INSERTED IT INTO THE K-WIRE HOLE. THE TIP OF THE K-WIRE REMAINED IN THE HOLE AND THE SURGEON HAD TO USE ANOTHER PLATE AND K-WIRE TO COMPLETE THE SURGERY. NO ADVERSE EVENTS TO THE PATIENT WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441871 STAINLESS STEEL K-WIRE 1.6MM PIN, FIXATION HTY BIOMET TRAUMA N/A 833060

    Patients

    Seq Age Sex Outcome Treatment
    1