BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAWS FOR 01.00529.102, PLASTIC

    MDR report key: 12576768 · Received October 5, 2021

    Report

    Report Number
    0009613350-2021-00516
    Event Type
    Malfunction
    Date Received
    October 5, 2021
    Date of Event
    September 7, 2021
    Report Date
    January 20, 2022
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    LXH
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS WERE MADE AVAILABLE. D10 CONCOMITANT MEDICAL PRODUCT: EXTRACTION INSTRUMENT, STRAIGHT. ITEM:0100529102; LOT: 4501960477. INVESTIGATION AND CONCLUSION: 1. EVENT DESCRIPTION: IT WAS REPORTED THAT DURING SURGERY, THE PLASTIC LINER BROKE WHILE TRYING TO REMOVE AN UNCEMENTED STEM FROM THE FEMORAL CANAL. THERE WAS NO DEBRIS IN THE PATIENT AND NO HARM. HARM: S1 - NO PATIENT, USER, OR OTHER STAKEHOLDER HARM. HAZARDOUS SITUATION: INSTRUMENT BREAKS, DIVERGES OR BECOMES DAMAGED AND NON-FUNCTIONAL DURING SURGICAL PROCEDURE. 2. REVIEW OF RECEIVED DATA: DUE DILIGENCE: NO FURTHER DUE DILIGENCE REQUIRED AS ALL REQUIRED INFORMATION TO SUPPORT THE CONCLUSION IS AVAILABLE OR WAS ALREADY REQUESTED. IMAGES: REVIEW OF THE RECEIVED IMAGES SHOWS THE BLACK PLASTIC COMPONENT IS SCRATCHED, GOUGED, AND FRACTURED. 3. PRODUCT EVALUATION: NO PRODUCT WAS RETURNED; THEREFORE, VISUAL AND DIMENSIONAL EVALUATION COULD NOT BE PERFORMED. 4. REVIEW OF PRODUCT DOCUMENTATION: DEVICE PURPOSE: THIS DEVICE IS INTENDED FOR TREATMENT. PRODUCT COMPATIBILITY: THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER BIOMET. 5. CONCLUSION: IT WAS REPORTED THAT DURING SURGERY, THE PLASTIC LINER BROKE WHILE TRYING TO REMOVE AN UNCEMENTED STEM FROM THE FEMORAL CANAL. THERE WAS NO DEBRIS IN THE PATIENT AND NO HARM. BASED ON THE INVESTIGATION THE REPORTED EVENT CAN BE CONFIRMED. THE INVESTIGATION DID NOT IDENTIFY A NONCONFORMANCE OR A COMPLAINT OUT OF BOX (COOB). BASED ON THE GIVEN INFORMATION AND THE RESULTS OF THE INVESTIGATION, WE WERE NOT ABLE TO IDENTIFY A SPECIFIC ROOT CAUSE FOR THIS ISSUE. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER SWITZERLAND MANUFACTURING GMBH CONSIDERS THIS CASE AS CLOSED. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4). THE FOLLOWING REPORT IS ASSOCIATED WITH THIS EVENT 0009613350-2021-00519-1.

    Description of Event or Problem · 0

    INVESTIGATION RESULTS ARE NOW AVAILABLE.

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET WINTERTHUR AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET WINTERTHUR MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE UNITED STATES. MEDICAL PRODUCTS: EXTRACTION INSTRUMENT, STRAIGHT; CATALOG#: 01.00529.102; LOT#: 4501960477. THE MANUFACTURER RECEIVED OTHER SOURCE DOCUMENTS FOR REVIEW. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. AS NO LOT NUMBER WAS PROVIDED, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. AS SOON AS SUPPLEMENTAL INFORMATION BECOMES AVAILABLE AN UPDATED REPORT WILL BE SUBMITTED. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    DURING A SURGERY WHILE EXTRACTION OF AN UNCEMENTED STEM FROM THE FEMORAL CANAL USING A FEMORAL EXTRACTION TOOL THE PLASTIC LINER BROKE. NO PLASTIC DEBRIS BROKE OFF AND NO DAMAGES DONE. THE INSTRUMENT WAS USED 20 TO 30 TIMES. NOTE: THE IMPLANTATION AND EXPLANTATION DATES ARE LEFT EMPTY AS THE DEVICE INVOLVED IN THIS COMPLAINT IS AN INSTRUMENT. HENCE, NO EXPIRATION DATE IS CAPTURED, FOR THE SAME REASON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1472204 JAWS FOR 01.00529.102, PLASTIC HIP INSTRUMENT LXH ZIMMER SWITZERLAND MANUFACTURING GMBH N/A 4501960477

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization