BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXF KNEE PH3 I/M ROD RMVL HK L HK

    MDR report key: 8686367 · Received June 11, 2019

    Report

    Report Number
    3002806535-2019-00496
    Event Type
    Malfunction
    Date Received
    June 11, 2019
    Date of Event
    May 10, 2019
    Report Date
    April 17, 2020
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LXH
    UDI-DI
    05019279469246
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FINAL REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. PRODUCTS HAVE BEEN RETURNED TO BIOMET UK LTD FOR EVALUATION AND FORWARDED TO THE COMPLAINTS PROCESSING UNIT FOR INVESTIGATION. THE REPORTED EVENT STATES THAT THE PIN FRACTURED DURING THE PROCEDURE AND FELL ON THE FLOOR, NO PART FELL IN THE PATIENT. NO PATIENT HARM OR DELAY TO PROCEDURE WAS REPORTED AND ALL FRACTURED SEGMENTS WERE RETRIEVED. THE SURGEON WAS NOT USING EXTRA STRENGTH THAN USUAL. VISUAL INSPECTION CONFIRMED THE REPORTED EVENT. THE PRODUCT WAS IN THE FIELD FOR APPROXIMATELY 2 YEARS AND 9 MONTHS. THE I/M ROD REMOVAL TOOL EXHIBITS SIGNS OF WEAR AND TEAR AROUND THE LOCATION WHERE THE PINS ARE ATTACHED TO THE SHAFT (SCRATCHES, NICKS, DENTS) CONSISTENT WITH DEVICE USAGE. THE LARGE PIN HAS FRACTURED AT THE POINT WHERE SILVER SOLDER IS APPLIED TO THE SHAFT. THE ROOT CAUSE OF THE PIN FRACTURING FROM THE SHAFT CANNOT BE FULLY DETERMINED, THE MOST LIKELY CAUSE IS THAT THE I/M ROD REMOVAL TOOL PINS HAVE RECEIVED EXCESSIVE FORCE OVER TIME. IT IS NOT POSSIBLE TO DETERMINE THE NUMBER OF PROCEDURES THIS INSTRUMENT HAS BEEN IN USE OVER THE 2 YEARS AND 9 MONTHS IT HAS BEEN IN THE FIELD. THE DHR RELATED TO THE INVOLVED PRODUCT HAS BEEN REVIEWED AND DOES NOT SHOW ANY NON-CONFORMITY, REJECTION OR CONCESSION THAT COULD BE RELATED TO THE REPORTED EVENT. ALL THE LOT ((B)(4) UNITS) WAS ACCEPTED AT THE TIME OF MANUFACTURING. A REVIEW OF THE COMPLAINT DATABASE HAS FOUND NO SIMILAR COMPLAINTS REPORTED WITH THIS ITEM / LOT COMBINATION. A REVIEW OF THE COMPLAINTS DATABASE FOR 3 YEARS PRIOR TO THE NOTIFICATION DATE HAS FOUND 4 SIMILAR REPORTED EVENTS, EXCLUDING THIS REPORTED EVENT, FOR ITEM NUMBER (B)(4). (B)(4) CONCLUDED THE ROOT CAUSE TO BE WEAR AND TEAR, (B)(4), PRODUCT NOT RETURNED FOR EVALUATION, (B)(4), INVESTIGATION ONGOING AND (B)(4), PRODUCT NOT YET RECEIVED FOR EVALUATION. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN THE COMPLAINT WILL BE REOPENED AND INVESTIGATED THOROUGHLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PARTIAL LEFT KNEE REPLACEMENT PROCEDURE, THE SURGEON WAS USING THE T-HANDLE TO REMOVE INTRAMEDULLARY ROD FROM THE PATIENT'S FEMUR WHEN THE LITTLE HOOK BROKE. ALL PIECES HAVE BEEN RETRIEVED FROM THE PATIENT.

    Additional Manufacturer Narrative · 1

    (B)(4). FOREIGN SOURCE: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PARTIAL LEFT KNEE REPLACEMENT PROCEDURE, THE SURGEON WAS USING THE T-HANDLE TO REMOVE INTRAMEDULLAR ROD FROM THE PATIENT'S FEMUR WHEN THE LITTLE HOOK BROKE. ALL PIECES HAVE BEEN RETRIEVED FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482678 OXF KNEE PH3 I/M ROD RMVL HK L HK ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH BIOMET UK LTD. N/A ZB170701 05019279469246

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention