BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 14711062 · Received June 16, 2022

    Report

    Report Number
    9613369-2022-00303
    Event Type
    Malfunction
    Date Received
    June 16, 2022
    Date of Event
    May 25, 2022
    Report Date
    September 9, 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
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE: (B)(4).

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT DURING A THR SURGERY, A PIECE OF THE SPRING DEVICE THAT ALLOWS THE ATTACHMENT OF SL-PLUS/SBG/IPA MIA OFFSET ADAPTER 10MM BROKE OFF. THE DEVICE IN QUESTION WAS RETURNED FOR INVESTIGATION. UPON VISUAL INSPECTION, THE REPORTED FAILURE MODE REGARDING THE BROKEN-OFF SPRING COULD BE CONFIRMED. THE MISSING SPRING WAS NOT RETURNED. A COMPLAINT HISTORY REVIEW WAS PERFORMED. NO OTHER COMPLAINTS REGARDING THE BATCH IN QUESTION WERE FOUND. THE REVIEW OF THE PRODUCTION DOCUMENTATION DID NOT DETECT ANY DEVIATIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED FAILURE MODE. THE PERFORMANCE OF THE DEVICE IS WITHIN THE RISKS, WHICH ARE ANTICIPATED IN THE RISK MANAGEMENT DOCUMENTATION OF THE PRODUCT, WHERE THE CORRESPONDING FAILURE MODE AND THE SEVERITY ARE COVERED. A REVIEW OF PAST CORRECTIVE ACTIONS WAS PERFORMED. NO FURTHER ESCALATION IS REQUIRED. ACCORDING TO THE PERFORMED INVESTIGATIONS, THE RELATIONSHIP BETWEEN THE REPORTED EVENT AND THE DEVICE WAS CONFIRMED. NO INDICATIONS THAT THE REPORTED DEVICE FAILED TO MEET MANUFACTURING SPECIFICATIONS UPON RELEASE FOR DISTRIBUTION WERE FOUND. THE ROOT CAUSE FOR THE FRACTURE COULD NOT BE IDENTIFIED AND STAYS UNDETERMINED. THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. WE REMIND TO FOLLOW OUR DOCUMENT "PROCESSING (CLEANING, DISINFECTION AND STERILIZATION) OF INSTRUMENTS FROM SMITH & NEPHEW ORTHOPAEDICS AG" (LIT. N°03389-EN 1363 V3 11/19) THAT ALL DEVICES MUST BE INSPECTED AND CONTROLLED FOR PROPER FUNCTIONING AFTER CLEANING/DISINFECTION. NEVERTHELESS, SMITH + NEPHEW WILL CONTINUE TO MONITOR THE DEVICE FOR SIMILAR ISSUES. THE RETURNED DEVICE WILL BE SCRAPPED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A THR SURGERY, A PIECE OF THE SPRING DEVICE THAT ALLOWS THE ATTACHMENT OF SL-PLUS/SBG/IPA MIA OFFSET ADAPTER 10MM BROKE OFF. THE PROCEDURE WAS COMPLETED, WITH A NON-SIGNIFICANT DELAY, USING A S+N BACK-UP DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1255671 SL-PLUS/SBG/IPA MIA OFFSET ADAPTER 10MM PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED KWY SMITH & NEPHEW ORTHOPAEDICS AG 75007309 G54925 07611996076394

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown