BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCR-C SCR 1.8X30MM CANN THD6

    MDR report key: 8018469 · Received October 30, 2018

    Report

    Report Number
    0009613350-2018-01110
    Event Type
    Malfunction
    Date Received
    October 30, 2018
    Report Date
    January 30, 2019
    Manufacturer
    ZIMMER GMBH
    Product Code
    HWC
    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

    INVESTIGATION RESULTS WERE MADE AVAILABLE. AS FOR ZIMMER SPECIALISTS TO PERFORM AN IN-DEPTH ANALYSIS IT IS REQUIRED TO HAVE ALL NECESSARY INFORMATION AT HAND, IT WAS THEREFORE TRIED SEVERAL TIMES TO RECEIVE ADDITIONAL INFORMATION FOR THIS CASE. DHR-REVIEW: AS NO LOT NUMBER WAS PROVIDED, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. THE MISSING DEVICE INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE. AT ZIMMER 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 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. TREND ANALYSIS: NO TREND CONSIDERING THE FOLLOWING EVENT IS IDENTIFIED: SCREW FRACTURED. EVENT DESCRIPTION: IT WAS REPORTED THAT THE SCREW BROKE DURING HAND SURGERY WHILE SCREWING IT IN THE DIP. MOREOVER, IT WAS COMMENTED, THAT THE SCREW WOULD HAVE A WALL THICKNESS OF A MERE 0.3MM AND WOULD BE VERY SENSITIVE TO TORSION, ESPECIALLY IF THESE FORCES WOULD BE ACTING UPON THE SCREWS FOR A LONGER TIME. THE LONGER THE SCREW, THE BIGGER THE TORSION FORCES. THIS WOULD BE GREATLY INFLUENCED BY THE SCREWS BEING SCREWED INTO SCLEROTIC BONES. REVIEW OF RECEIVED DATA: NO MEDICAL DATA SUCH AS X-RAYS, SURGICAL NOTES OR ANY OTHER CASE-RELEVANT DOCUMENTS RECEIVED. DEVICES ANALYSIS: NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS. REVIEW OF PRODUCT DOCUMENTATION: NO PRODUCT DOCUMENTATION WAS REVIEWED FOR INVESTIGATION. CONCLUSION SUMMARY: IT WAS REPORTED THAT THE SCREW FRACTURED WHILE SCREWING IT INTO THE BONE. THE MANUFACTURING DOCUMENTS COULD NOT BE REVIEWED, AS THE LOT NUMBER OF THE DEVICE REMAINS UNKNOWN. MOREOVER, THE IMPLANT HAS NOT BEEN RETURNED FOR AN INVESTIGATION. CONSIDERING THE SECOND REPORTED EVENT WITHIN THIS PER, NO FURTHER SIMILAR EVENTS HAVE BEEN REPORTED FOR THIS PART NUMBER. IT MIGHT BE THAT EXCESSIVELY HIGH TORQUE FORCES MIGHT HAVE BEEN APPLIED ON THE SCREW DURING ITS INSERTION, LEADING TO THE FRACTURE. MOREOVER, THE QUALITY (I.E. DENSITY) OF THE PATIENT'S BONE MIGHT HAVE ALSO CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. HOWEVER, BASED ON THE AVAILABLE INFORMATION, NO EXACT ROOT CAUSE COULD BE DETERMINED. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER GMBH CONSIDERS THIS CASE AS CLOSED. ZIMMER BIOMET'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 0

    NO NEW INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). AS NO LOT NUMBER WAS PROVIDED, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. THE MANUFACTURER DID NOT RECEIVE X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS CURRENTLY NOT AVAILABLE. 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SURGEON CLAIMS THAT ONE SCREW BROKE WHILST BEING SCREWED. ALL OF THE BROKEN FRAGMENTS WERE REMOVED AND DISPOSED OF DURING THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    861543 MCR-C SCR 1.8X30MM CANN THD6 N/A HWC ZIMMER GMBH N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1