BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SL-PLUS/SBG/IPA MIA OFFSET ADAPTER 40MM

    MDR report key: 14492566 · Received May 24, 2022

    Report

    Report Number
    9613369-2022-00264
    Event Type
    Malfunction
    Date Received
    May 24, 2022
    Date of Event
    May 2, 2022
    Report Date
    June 17, 2022
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS AG
    Product Code
    JDI
    UDI-DI
    07611996074895
    PMA / PMN Number
    K123598
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    H10: IT WAS REPORTED THAT, DURING TOTAL HIP REPLACEMENT, A 40MM OFFSET ADAPTER BROKE OUTSIDE THE PATIENT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A SMITH & NEPHEW BACK-UP DEVICE. THE DEVICE, USED IN TREATMENT, WAS RETURNED FOR INVESTIGATION. UPON VISUAL INSPECTION, THE FRACTURE AT THE CONNECTION BETWEEN THE CONTACT PIN AND THE BODY OF THE ADAPTER COULD BE CONFIRMED. THE FAILURE MODE AND THE SEVERITY ARE COVERED THROUGH OUR RISK MANAGEMENT. A REVIEW OF PAST CORRECTIVE ACTIONS WAS PERFORMED. NO FURTHER ESCALATION IS REQUIRED. REVIEW OF THE PRODUCTION DOCUMENTATION DID NOT DETECT ANY DEVIATION THAT COULD HAVE CONTRIBUTED TO THE REPORTED FAILURE MODE. ONE ADDITIONAL COMPLAINT WAS DETECTED FOR THE BATCH IN QUESTION. HOWEVER, THIS INSTRUMENT IS DESIGNED TO HOLD AND GUIDE THE DETACHABLE RASPS FOR BROACHING. IT IS THEREFORE SUBJECTED TO REPEATED IMPACT FORCES VIA THE MODULAR KNOCK PLATE OR THE PNEUMATIC WOODPECKER. PREVIOUS INVESTIGATIONS DEMONSTRATED, THAT UNDER SPECIFIC CIRCUMSTANCES, THIS DEVICE MAY FRACTURE DURING IMPACTION. AN OPTIMIZED DESIGN OF THE DEVICE HAS BEEN RELEASED IN ORDER TO REDUCE THE OCCURRENCE OF THIS ISSUE. ACCORDING TO DOCUMENT "PROCESSING (CLEANING, DISINFECTION AND STERILIZATION) OF INSTRUMENTS FROM SMITH & NEPHEW ORTHOPAEDICS AG", ALL INSTRUMENTS 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. INTERNAL COMPLAINT REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING TOTAL HIP REPLACEMENT, A 40MM OFFSET ADAPTER BROKE OUTSIDE THE PATIENT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A SMITH & NEPHEW BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2202982 SL-PLUS/SBG/IPA MIA OFFSET ADAPTER 40MM PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI SMITH & NEPHEW ORTHOPAEDICS AG 75007308 H58205 07611996074895

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown