BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SL/SBG/IPA MIA DOUBLE OFFSET ADAP.R17/13

    MDR report key: 11952784 · Received June 7, 2021

    Report

    Report Number
    9613369-2021-00277
    Event Type
    Malfunction
    Date Received
    June 7, 2021
    Date of Event
    May 25, 2021
    Report Date
    September 14, 2021
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS AG
    Product Code
    JDI
    UDI-DI
    07611996085464
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, THE LOCKING SPRING OF THE DOUBLE OFFSET ADAPTER 17/13MM RIGHT WAS TAKEN OFF. THERE WAS A SURGICAL DELAY OF 5 MIN AND A SMITH AND NEPHEW BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. THE OFFSET ADAPTER DEVICE, INTENDED FOR USE IN TREATMENT, WAS RETURNED FOR INVESTIGATION. UPON VISUAL INSPECTION, THE FAILURE MODE AND THE RELATIONSHIP BETWEEN THE REPORTED EVENT AND THE DEVICE WAS CONFIRMED. THE PIN AND LOCKING KEY WERE NOT CONNECTED TO THE BASE BODY ANYMORE. THE DEVICE SHOWS NORMAL SIGNS OF USAGE SUCH AS SMALL SCRATCHES AND DENTS. FURTHERMORE, THE RELEVANT DRILL HOLE ITSELF LOOKS PROPERLY MACHINED. THE PROTRUSION AT THE TIP OF THE PIN IS VISIBLE, WHICH MEANS THAT THE PIN WAS RIVETED AT THE TIME OF MANUFACTURING. THE RELEVANT DIMENSIONS OF THE BASE BODY AND THE PIN WERE MEASURED IN THE METROLOGY DEPARTMENT. BASED ON THE MEASURED DIMENSIONS, A PERFORMED TOLERANCE ANALYSIS REVEALED THAT A PROPER RIVETING WAS STILL POSSIBLE AT THE TIME OF MANUFACTURING AND THE PIN COULD WIDEN AND RESULT IN A CLAMPING DUE TO RIVETING. HENCE, THERE IS NO INDICATION THAT THE REPORTED DEVICE FAILED TO MEET CRUCIAL MANUFACTURING SPECIFICATIONS UPON RELEASE FOR DISTRIBUTION. A REVIEW OF THE PRODUCTION DOCUMENTATION DID NOT REVEAL ANY DEVIATION FROM THE STANDARD OPERATING PROCEDURE. THE DEVICE IN QUESTION WAS MANUFACTURED IN YEAR 2009. FURTHERMORE, NO ADDITIONAL COMPLAINT WITH BATCH D66537 WAS REPORTED SO FAR AND FOR THE 17/13MM OFFSET ADAPTER RIGHT, NO ADDITIONAL COMPLAINT WITH A REPORTED LOOSE PIN WAS DETECTED. AS NO PATIENT INJURY WAS REPORTED, NO FURTHER CLINICAL/MEDICAL ASSESSMENT IS WARRANTED AT THIS TIME. BASED ON THE PERFORMED INVESTIGATIONS, THE PROBABLE CAUSE FOR THE PIN LOOSENING IS ATTRIBUTED TO A WEAR AND TEAR ISSUE THROUGH REPEATED USE OVER TIME. 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. TO DATE, NO FURTHER ACTIONS ARE DEEMED NECESSARY. SMITH AND NEPHEW WILL CONTINUE TO MONITOR THE DEVICE FOR SIMILAR ISSUES. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS COMPLAINT WILL BE REASSESSED.

    Additional Manufacturer Narrative · 0

    (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING AN UNKNOWN SURGERY, THE LOCKING SPRING OF A SL/SBG/IPA MIA DOUBLE OFFSET ADAP.R17/13 WAS TAKEN OFF. THERE WAS A SURGICAL DELAY OF 5 MIN WAS REPORTED, AND A SMITH AND NEPHEW BACKUP DEVICE WAS AVAILABLE TO CONCLUDE THE PROCEDURE. NEITHER PATIENT INJURY NOR OTHER COMPLICATIONS WERE REPORTED DUE TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING AN UNKNOWN SURGERY, THE LOCKING SPRING OF A SL/SBG/IPA MIA DOUBLE OFFSET ADAP.R17/13 WAS TAKEN OFF. THERE WAS A SURGICAL DELAY OF 5 MIN WAS REPORTED, AND A SMITH AND NEPHEW BACKUP DEVICE WAS AVAILABLE TO CONCLUDE THE PROCEDURE. NEITHER PATIENT INJURY NOR OTHER COMPLICATIONS WERE REPORTED DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    844079 SL/SBG/IPA MIA DOUBLE OFFSET ADAP.R17/13 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI SMITH & NEPHEW ORTHOPAEDICS AG 75004612 D66537 07611996085464

    Patients

    Seq Age Sex Outcome Treatment
    1