BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SL-PLUS/SBG/IPA MIA OFFSET ADAPTER 10MM

    MDR report key: 12599248 · Received October 8, 2021

    Report

    Report Number
    9613369-2021-00381
    Event Type
    Malfunction
    Date Received
    October 8, 2021
    Date of Event
    September 27, 2021
    Report Date
    December 24, 2021
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS AG
    Product Code
    JDI
    UDI-DI
    07611996076394
    PMA / PMN Number
    K123598
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H3, H6: IT WAS REPORTED THAT A SL-PLUS/SBG/IPA MIA OFFSET ADAPTER 10MM WAS FOUND TO HAVE THE TIP BROKEN OFF. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NO PATIENT INVOLVEMENT. THE COMPLAINT DEVICE, WHICH INTENT USE IS TREATMENT, WAS RETURNED FOR INVESTIGATION. THE REPORTED ISSUE WAS CONFIRMED UPON VISUAL INSPECTION, THE TIP OF THE INSTRUMENT IS FRACTURED. A COMPLAINT HISTORY REVIEW SHOWED NO FURTHER COMPLAINTS OF DEVICES FROM THE SAME BATCH. A REVIEW OF THE PRODUCTION DOCUMENTATION FOR THE BATCH IN SCOPE DID NOT REVEAL ANY DEVIATION FROM THE STANDARD OPERATING PROCEDURE AND A MATERIAL ANALYSIS CONFIRMED THE SPECIFICATION OF THE MATERIAL. THERE IS NO INDICATION THAT THE REPORTED DEVICE FAILED TO MEET MANUFACTURING SPECIFICATIONS UPON RELEASE FOR DISTRIBUTION. THE FAILURE MODE AND THE SEVERITY ARE COVERED IN THE CORRESPONDING RISK MANAGEMENT FILE. A REVIEW OF PAST CORRECTIVE ACTIONS WAS PERFORMED. NO FURTHER ESCALATION IS REQUIRED. A RELATIONSHIP BETWEEN THE REPORTED EVENT AND THE DEVICE COULD BE CONFIRMED. BASED ON THE PERFORMED INVESTIGATIONS, THE PROBABLE CAUSE COULD NOT BE DETERMINED. AS THIS INSTRUMENT WAS PRODUCED IN 2010, NORMAL WEAR AND TEAR THROUGH REPEATED USE IS KNOWN TO CONTRIBUTE TO THE REPORTED EVENT. ACCORDING TO DOCUMENT "PROCESSING (CLEANING, DISINFECTION AND STERILIZATION) OF INSTRUMENTS FROM SMITH & NEPHEW ORTHOPAEDICS AG" (LIT. N°03389-EN 1363 V3 11/19), ALL DEVICES MUST BE INSPECTED AND CONTROLLED FOR PROPER FUNCTIONING AFTER CLEANING/DISINFECTION. NO FURTHER ACTIONS ARE DEEMED NECESSARY. THIS VERSION OF THE DEVICE WILL BE MONITORED FOR SIMILAR ISSUES. THIS INVESTIGATION IS CONSIDERED CLOSED. THE COMPLAINT DEVICE WILL BE RETAINED.

    Additional Manufacturer Narrative · 1

    INTERNAL COMPLAINT REFERENCE CASE (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SL-PLUS/SBG/IPA MIA OFFSET ADAPTER 10MM WAS FOUND TO HAVE THE TIP BROKEN OFF. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1494870 SL-PLUS/SBG/IPA MIA OFFSET ADAPTER 10MM PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI SMITH & NEPHEW ORTHOPAEDICS AG 75007309 F70955 07611996076394

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown