BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SETTING INSTRUMENT FOR POLE PLUG

    MDR report key: 17189596 · Received June 23, 2023

    Report

    Report Number
    0009613350-2023-00333
    Event Type
    Malfunction
    Date Received
    June 23, 2023
    Report Date
    June 23, 2023
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    LZO
    UDI-DI
    00889024413375
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCT: ALPHA TRAY FOR TRIAL INSERTS, PLASTIC; ITEM# 01.00019.300; LOT# 4503141122; ALPHA TRAY, PLASTIC, EMPTY; ITEM# 01.00019.101; LOT# 4503048686. REPORT SOURCE FOREIGN: POLAND. VISUAL EXAMINATION: THE TIP OF THE INSTRUMENT IS FRACTURED OFF AND THE RING IS MISSING. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS. DEVICE IS USED FOR TREATMENT. AN INVESTIGATION WAS PREVIOUSLY PERFORMED INCLUDING THE INITIATION OF CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) AND HEALTH HAZARD EVALUATION TO ASSESS THE NECESSITY OF CORRECTIVE ACTIONS AND/OR A FIELD ACTION. THE CAPA INVESTIGATION CONCLUDED THE BELOW ROOT CAUSES: SURGEON HAS LIMITED VISIBILITY OF THE PLUG DURING INSERTION WITH THE STRAIGHT SETTING DEVICE. THE SURGEON MAY NOT SEE WHEN THE POLE PLUG IS FULLY SEATED (LEADING TO A POTENTIAL DEFORMATION OF THE INSTRUMENT TIP). THE DESCRIBED SURGICAL TECHNIQUE IS NOT ALWAYS FOLLOWED AND THE INSTRUMENT HAS BEEN MISUSED. BOTH SURGICAL TECHNIQUES OF THE ALLOCLASSIC CUP AND ALLOCLASSIC IT CUP DO DESCRIBE THE CORRECT HANDLING OF THE POLE PLUG INSERTER. HOWEVER, THE DESCRIPTIONS OF HOW TO USE THE SETTING INSTRUMENT ARE NOT FULLY ALIGNED. A CAD ANALYSIS SHOWED THAT A POTENTIAL MINIMAL COLLISION BETWEEN THE INSTRUMENT AND THE ACETABULAR CUP MAY HAPPEN DURING THE INSERTION OF THE POLE PLUG. THIS COLLISION MAY RESULT IN THE INSTRUMENT SLIGHTLY SEPARATING FROM THE POLE PLUG, WHICH MAY LEAD TO A DEFORMATION OF THE SETTING INSTRUMENT. CORRECTIVE ACTIONS RELATED TO THE AFFECTED SETTING INSTRUMENT HAVE BEEN IMPLEMENTED. THESE CORRECTIVE ACTIONS INCLUDE THE FOLLOWING: THE DESIGN OF THE INSTRUMENT WAS IMPROVED. THE VISIBILITY OF THE SURGICAL FIELD WAS IMPROVED BY FLATTENING THE TIP OF THE STRAIGHT SETTING INSTRUMENT AND THE POTENTIAL WORST CASE COLLISION/OVERLAP BETWEEN INSTRUMENT AND ACETABULAR CUP WAS ELIMINATED. A SURGICAL TECHNIQUE AMENDMENT WAS IMPLEMENTED. THE DESCRIPTIONS OF THE CUP SURGICAL TECHNIQUE WAS ALIGNED WITH THE DESCRIPTION IN THE SURGICAL TECHNIQUE OF THE IT CUP. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SETTING INSTRUMENT IS FRACTURED AND THE RING IS MISSING. NO PATIENT HARM OR INVOLVEMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2222435 SETTING INSTRUMENT FOR POLE PLUG HIP INSTRUMENT LZO ZIMMER SWITZERLAND MANUFACTURING GMBH N/A 4503475275 00889024413375

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown