BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 10394243 · Received August 11, 2020

    Report

    Report Number
    9613369-2020-00154
    Event Type
    Malfunction
    Date Received
    August 11, 2020
    Date of Event
    July 16, 2020
    Report Date
    September 21, 2020
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE TIP OF THE SL-PLUS/SBG/IPA MIA OFFSET ADAPTER 40MM WHICH CONNECTS ONTO THE BROACH HANDLE PLATE BROKE OFF WHILE IMPACTING. ITEM BROKE OUTSIDE OF THE PATIENT. NO INJURIES OR SURGICAL DELAYS REPORTED. PROCEDURE WAS COMPLETED WITH AN S+N BACKUP DEVICE. THE COMPLAINT DEVICE, USED IN TREATMENT, WAS RETURNED FOR INVESTIGATION. THE REPORTED FAILURE MODE COULD BE CONFIRMED UPON VISUAL INSPECTION. ADDITIONALLY, THE INSTRUMENT SHOWED SIGNS OF USE. THE COMPLAINT HISTORY REVIEW WAS PERFORMED, NO FURTHER COMPLAINTS WITH DEVICES OF THE SAME BATCH WERE FOUND. THE PRODUCTION DOCUMENTATION REVIEW DID NOT FIND ANY DEVIATIONS FROM THE STANDARD MANUFACTURING PROCEDURE WHICH COULD HAVE CONTRIBUTED TO THE ISSUE. BASED ON THE CONDUCTED INVESTIGATION, THERE ARE NO INDICATIONS THAT THE COMPLAINT PART DID NOT MEET THE SPECIFICATIONS AT THE TIME OF MANUFACTURING AND THE ROOT CAUSE COULD NOT BE DETERMINED CONCLUSIVELY. NO FURTHER ACTIONS ARE DEEMED NECESSARY. SMITH+NEPHEW WILL CONTINUE TO MONITOR FOR SIMILAR ISSUES. THE DEVICE WILL BE DISCARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TAT THE TIP OF THE SL-PLUS/SBG/IPA MIA OFFSET ADAPTER 40MM THAT CONNECTS ONTO BROACH HANDLE PLATE BROKE OFF WHILE IMPACTING. ITEM BROKE OUTSIDE THE PATIENT. NO INJURIES OR SURGICAL DELAYS REPORTED. PROCEDURE WAS FINISHED WITH AN S+N BACKUP DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    858096 SL-PLUS/SBG/IPA MIA OFFSET ADAPTER 40MM PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI SMITH & NEPHEW ORTHOPAEDICS AG 75007308 600921 07611996074895

    Patients

    Seq Age Sex Outcome Treatment
    1