BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAGNER SL REVISION, TRIAL STEM, DISTAL, 15

    MDR report key: 12712261 · Received October 28, 2021

    Report

    Report Number
    0009613350-2021-00545
    Event Type
    Injury
    Date Received
    October 28, 2021
    Report Date
    December 10, 2021
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    LZO
    UDI-DI
    00889024277816
    PMA / PMN Number
    K191781
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS WERE MADE AVAILABLE. 1. EVENT DESCRIPTION: IT WAS REPORTED THAT THE TRIAL INSTRUMENT WAS BROKEN DURING SURGERY. HARM: S2 - EXPOSURE TO ANESTHESIA, MINOR. HAZARDOUS SITUATION: INSTRUMENT BREAKS, DIVERGES OR BECOMES DAMAGED AND NON-FUNCTIONAL DURING SURGICAL PROCEDURE. 2. REVIEW OF RECEIVED DATA: NO MEDICAL DATA RELEVANT TO THE CASE HAS BEEN RECEIVED. DUE DILIGENCE: NO FURTHER DUE DILIGENCE REQUIRED AS ALL REQUIRED INFORMATION TO SUPPORT THE CONCLUSION IS AVAILABLE OR WAS ALREADY REQUESTED. 3. PRODUCT EVALUATION: NO PRODUCT WAS RETURNED; THEREFORE, VISUAL AND DIMENSIONAL EVALUATION COULD NOT BE PERFORMED. 4. REVIEW OF PRODUCT DOCUMENTATION: DOCUMENT REVIEW COULD NOT BE PERFORMED DUE TO UNKNOWN PRODUCT IDENTIFICATION. DEVICE PURPOSE: ALL INVOLVED DEVICES ARE INTENDED FOR TREATMENT. PRODUCT COMPATIBILITY: THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER BIOMET. 5. CONCLUSION: IT WAS REPORTED THAT THE TRIAL INSTRUMENT WAS BROKEN DURING SURGERY. NEITHER THE DEVICE NOR PHOTOS OF THE DEVICE WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENT IS UNKNOWN. BASED ON THE INVESTIGATION THE REPORTED EVENT CANNOT BE CONFIRMED. DUE TO SIGNIFICANT LACK OF INFORMATION A DETAILED INVESTIGATION COULD NOT BE PERFORMED, NEVERTHELESS BASED ON THE GIVEN INFORMATION THERE IS NO INDICATION OF A NONCONFORMANCE OR COMPLAINT OUT OF BOX (COOB). AS NO LOT NUMBERS WERE PROVIDED FOR THE DEVICES, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. THE MISSING DEVICE INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE. AT ZIMMER SWITZERLAND MANUFACTURING GMBH ALL MEDICAL DEVICES PRIOR RELEASE TO MARKET UNDERGO SEVERAL QUALITY INSPECTIONS AS DEFINED IN OUR QUALITY PROCEDURES. OUR QUALITY INSPECTION AND DEVIATION PROCEDURES ENSURE THAT ONLY PRODUCTS FULFILLING THE SPECIFICATION ARE SOLD. THESE PROCEDURES ARE PART OF THE OVERALL QUALITY MANAGEMENT SYSTEM AT ZIMMER SWITZERLAND MANUFACTURING GMBH AND GET REGULARLY AUDITED BY OUR NOTIFIED BODY, COMPETENT AUTHORITIES AND INTERNAL AND EXTERNAL AUDITORS. THUS, FOR ALL PRODUCTS SOLD TO THE MARKET CAN BE ASSUMED HAVING A COMPLETE AND CORRECT DHR. 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).

    Description of Event or Problem · 0

    INVESTIGATION RESULTS ARE NOW AVAILABLE.

    Additional Manufacturer Narrative · 1

    MEDICAL PRODUCT: WAGNER SL REVISION, SCREW FOR TRIAL STEM, L 225. CATALOG#: 01.00109.805; LOT#: UNKNOWN. THERAPY DATE: UNKNOWN. THE MANUFACTURER DID NOT RECEIVE X-RAYS, OR 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

    IT WAS REPORTED THAT THE INSTRUMENT WAS FRACTURED DURING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1607234 WAGNER SL REVISION, TRIAL STEM, DISTAL, 15 WAGNER SL REVISION STEM LATERAL SYSTEM LZO ZIMMER SWITZERLAND MANUFACTURING GMBH N/A UNKNOWN 00889024277816

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization SEE H10 NARRATIVE