BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIRUS, TROCAR, 8 MM

    MDR report key: 11071771 · Received December 24, 2020

    Report

    Report Number
    0009613350-2020-00618
    Event Type
    Malfunction
    Date Received
    December 24, 2020
    Date of Event
    December 3, 2020
    Report Date
    July 13, 2021
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    KBG
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED AND ADDITIONAL INFORMATION. EVENT DESCRIPTION: IT WAS REPORTED THAT DURING A REVITAN IMPLANTATION, DURING INSERTION OF THE TROCAR INTO THE TISSUE PROTECTION SLEEVE, THE TROCAR JAMMED AND COULD NO LONGER BE MOVED. THE TARGETING MODULE WAS DISMANTLED AND THE REVITAN STEM WAS LOCKED UNDER X-RAY CONTROL. THE TARGETING MODULE, THE TISSUE PROTECTION SLEEVE AND THE TROCAR COULD NOT BE SEPARATED FROM EACH OTHER EVEN AFTER THE SURGERY. THE INSTRUMENTS WERE USED FOR AROUND 6 YEARS. A SURGICAL DELAY OF AROUND 30 MIN WAS NOTED. REVIEW OF RECEIVED DATA: NO MEDICAL DATA HAS BEEN RECEIVED DUE TO PATIENT PRIVACY POLICY. DUE DILIGENCE: NO FURTHER DUE DILIGENCE REQUIRED AS ALL REQUIRED INFORMATION TO SUPPORT THE CONCLUSION IS AVAILABLE OR WAS ALREADY REQUESTED. PRODUCT EVALUATION: VISUAL EXAMINATION: THE TARGETING MODULE WAS RECEIVED WITH THE TISSUE PROTECTION SLEEVE AND TROCAR MOUNTED. THE TROCAR IS JAMMED WITHIN THE TISSUE PROTECTION SLEEVE AND CANNOT BE REMOVED BY HAND. THE TIP OF THE TISSUE PROTECTION SLEEVE VISIBLE IN THE BORE HOLE OF THE TARGETING MODULE IS DEFORMED. IN ADDITION, THE TIP OF THE TROCAR HAS INDENTATIONS AND THE BORE HOLE OF THE TARGETING MODULE HAS DRILL MARKS, POSSIBLY DERIVING FROM ATTEMPTS TO REMOVE OF THE TROCAR. AFTER INSPECTION OF THE ASSEMBLED COMPONENTS, THE TROCAR COULD BE PUSHED OUT OF THE TISSUE PROTECTION SLEEVE BY HAMMER BLOWS TO THE TIP OF THE TROCAR. THE TIP OF THE REMOVED TROCAR SHOWS INDENTATIONS AND WEAR. THE TISSUE PROTECTION SLEEVE IS JAMMED INSIDE THE TARGETING MODULE TO SUCH AN EXTENT THAT IT COULD NOT BE REMOVED. REVIEW OF PRODUCT DOCUMENTATION: DEVICE PURPOSE: ALL INVOLVED DEVICES ARE INTENDED FOR TREATMENT. PRODUCT COMPATIBILITY: THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER BIOMET. DHR REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. NCRS: NO NCR WITH A POTENTIAL CORRELATION TO THE REPORTED EVENT WAS FOUND. CONCLUSION: IT WAS REPORTED THAT DURING A REVITAN IMPLANTATION, DURING INSERTION OF THE TROCAR INTO THE TISSUE PROTECTION SLEEVE, THE TROCAR JAMMED AND COULD NO LONGER BE MOVED. THE TARGETING MODULE WAS DISMANTLED AND THE REVITAN STEM WAS LOCKED UNDER X-RAY CONTROL. THE TARGETING MODULE, THE TISSUE PROTECTION SLEEVE AND THE TROCAR COULD NOT BE SEPARATED FROM EACH OTHER EVEN AFTER THE SURGERY. THE INSTRUMENTS WERE USED FOR AROUND 6 YEARS. A SURGICAL DELAY OF AROUND 30 MIN WAS NOTED. DURING THE VISUAL EXAMINATION, IT WAS FOUND THAT THE TISSUE PROTECTION SLEEVE JAMMED IN THE TARGETING MODULE WAS FOUND TO BE DEFORMED AND THEREFORE COULD NOT BE REMOVED FROM THE TARGETING MODULE. THE TROCAR COULD BE REMOVED FROM THE TISSUE PROTECTION SLEEVE AND SHOWS SOME SIGNS OF WEAR AND INDENTATIONS AT THE TIP, MOST LIKELY FROM REMOVAL ATTEMPTS. THE QUALITY RECORDS SHOW THAT ALL SPECIFIED CHARACTERISTICS HAVE MET THE SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. THEREFORE, THE INVESTIGATION DID NOT IDENTIFY A NONCONFORMANCE OR A COMPLAINT OUT OF BOX (COOB). THE INVOLVED DEVICES WERE MANUFACTURED BETWEEN 2004 AND 2006 AND SHOW SIGNS OF WEAR AND TEAR. THEREFORE, BASED ON THE VISUAL EXAMINATION IT CAN BE ASSUMED, THAT THE TISSUE PROTECTION SLEEVE HAS JAMMED IN THE TARGETING MODULE DUE TO DEFORMATION DUE TO REPEATED USE, CLEANING AND STERILIZATION. NEVERTHELESS, AN EXACT ROOT CAUSE COULD NOT BE FOUND. 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

    NO CHANGE TO PREVIOUSLY REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID RECEIVE PER 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 SURGERY WHEN INSERTING THE TROCAR IT GOT JAMMED AND COULD NO LONGER BE MOVED. THE AIMING ARM INSTRUMENTS WERE DISMANTLED AND THE REVITAN SHAFT WAS LOCKED WITH A RADIOLUCENT BEVEL GEAR. THE INSTRUMENTS COULD NOT BE SEPARATED FROM EACH OTHER EVEN AFTER THE OPERATION. THE INSTRUMENT WAS USED ABOUT 6 YEARS. 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
    1535054 SIRUS, TROCAR, 8 MM N/A KBG ZIMMER SWITZERLAND MANUFACTURING GMBH N/A 04.134159

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization