BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 14462433 · Received May 20, 2022

    Report

    Report Number
    9613369-2022-00261
    Event Type
    Malfunction
    Date Received
    May 20, 2022
    Date of Event
    April 26, 2022
    Report Date
    June 28, 2022
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS AG
    Product Code
    KWY
    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

    INTERNAL COMPLAINT REFERENCE: CASE (B)(4).

    Additional Manufacturer Narrative · 0

    H3, H6: IT WAS REPORTED THAT A SL-PLUS/SBG/IPA MIA OFFSET ADAPTER 10MM WAS FOUND TO BE BROKEN. A VISUAL INSPECTION OF THE RETURNED DEVICE CONFIRMED THE STATED FAILURE MODE. THE RELEASE LEVER IS FRACTURED ON THE OPPOSING SIDE TO THE ACTUATING AREA OF THE LEVER. THE FRAGMENT WAS NOT RETURNED FOR INVESTIGATION. APART FROM THE FRACTURE, THE INSTRUMENT SHOWS SIGNS OF WEAR AS IT CAN BE EXPECTED AFTER REPEATED USE OVER TIME. A REVIEW OF THE COMPLAINT HISTORY OF THE AFFECTED DEVICE WAS PERFORMED. NO ADDITIONAL COMPLAINT FOR THE BATCH IN QUESTION WAS DETECTED. FOR THE DEVICE 75007309, ONE ADDITIONAL COMPLAINT WITH A COMPARABLE FAILURE MODE WAS REPORTED IN 2010. A REVIEW OF THE PRODUCTION DOCUMENTATION DID NOT DETECT ANY DEVIATION THAT COULD HAVE CONTRIBUTED TO THE REPORTED FAILURE MODE. THE PART WAS MANUFACTURED IN 2008. THE FUNCTION OF THE COMPLAINT INSTRUMENT IN COMBINATION WITH A RASP WAS TESTED BY USING THE RESPECTIVE TEST GAUGE. NO DEVIATION WAS DETECTED. HENCE, THE FUNCTIONALITY OF THE INSTRUMENT IS MAINTAINED DESPITE THE DAMAGE. A REVIEW OF THE RISK MANAGEMENT DOCUMENTATION VERIFIES THE FAILURE MODE AND SEVERITY OF THE REPORTED ISSUE. THE RELEASE LEVER OF THE DEVICE IS DESIGNED AS A SPRING WHICH IS THEREFORE SUBJECTED TO REPEATED COMPRESSIVE FORCES WHEN CONNECTING AND DISCONNECTING THE DEVICE WITH A BROACH. PREVIOUS INVESTIGATIONS REVEALED THAT UNDER SPECIFIC CIRCUMSTANCES, THIS RELEASE LEVER OF THE DEVICE MAY FRACTURE DURING COMPRESSION. THE ROOT CAUSE IS ATTRIBUTED TO A DESIGN ISSUE. A NEW DESIGN OF THE DEVICE HAS BEEN RELEASED IN ORDER TO REDUCE THE REOCCURRENCE OF THIS ISSUE. THIS VERSION OF THE DEVICE WILL BE MONITORED FOR SIMILAR ISSUES. THE PERFORMANCE OF THE DEVICE IS NONETHELESS WITHIN THE RISKS, WHICH ARE ANTICIPATED IN THE RISK MANAGEMENT DOCUMENTATION OF THE PRODUCT. NO FURTHER ESCALATION IS REQUIRED. PLEASE NOTE THAT 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. THIS VERSION OF THE DEVICE WILL BE MONITORED FOR SIMILAR ISSUES. THE RETURNED DEVICE WILL BE DISCARDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SL-PLUS/SBG/IPA MIA OFFSET ADAPTER 10MM WAS FOUND TO BE BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526415 SL-PLUS/SBG/IPA MIA OFFSET ADAPTER 10MM PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED KWY SMITH & NEPHEW ORTHOPAEDICS AG 75007309 E59831 07611996076394

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown