BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 11654378 · Received April 13, 2021

    Report

    Report Number
    9613369-2021-00155
    Event Type
    Malfunction
    Date Received
    April 13, 2021
    Date of Event
    March 19, 2021
    Report Date
    July 8, 2021
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS AG
    Product Code
    JDI
    UDI-DI
    07611996076394
    PMA / PMN Number
    K123598
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT WHEN ATTACHING THE FIRST BROACH TO THE BROACH HANDLE, THE BROACH FELL OFF THE OF THE HANDLE. THEN, IT WAS NOTICED THAT THE LOCKING MECHANISM OF THE SL-PLUS/SBG/IPA MIA OFFSET ADAPTER 10MM [ARTICLE NO.: 75007309, LOT: E59830] WAS BROKEN. THE OFFSET BROACH HANDLE WAS USED INSTEAD WITH NO ADVERSE CONSEQUENCES. THIS WAS NOTICED DURING SET UP/INSPECTION. THE CLAIMED ARTICLE, WHICH INTENT USE IS IN TREATMENT, WAS RETURNED FOR INVESTIGATION. THE REPORTED FAILURE CAN BE CONFIRMED. THE DEVICE IS FRACTURED AT THE LOCKING MECHANISM. THE HOOK WAS BROKEN OFF. THE REVIEW OF THE ORDER DOCUMENTATION DID NOT REVEAL ANY DEVIATION WHICH COULD RELATE TO THE REPORTED FAILURE. A COMPLAINT HISTORY REVIEW WAS PERFORMED: FOR THE BATCH IN SCOPE NO OTHER COMPLAINT WAS RECORDED. FOR THE SPECIFIC ARTICLE NUMBER OVERALL 8 COMPLAINTS ARE RECORDED WHICH STATE A FRACTURE OF THE DEVICE. DUE TO THE PERFORMED COMPLAINT REVIEW IT WILL NOT ASSUMED THAT A MANUFACTURING ERROR HAPPENED. THE IFU (LIT. NO. 12.23 ED 05/16) REQUIRES "BEFORE USE, THE FUNCTIONALITY OF SURGICAL INSTRUMENTS SHOULD BE CHECKED." ALL REUSABLE INSTRUMENTS SHALL THEREFORE BE ROUTINELY INSPECTED FOR FUNCTIONALITY, WEAR AND DAMAGE AND REPLACED AS NECESSARY. TO DATE, NO FURTHER ACTIONS WILL BE TAKEN. THE ROOT CAUSE WILL BE STATE TO "CAUSE TRACED TO COMPONENT FAILURE". THE DEVICE WILL BE DISCARDED. SMITH & NEPHEW WILL MONITOR THIS DEVICE FOR SIMILAR ISSUES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN ATTACHING THE FIRST BROACH TO THE BROACH HANDLE, THE BROACH FELL OFF THE OF THE HANDLE. THEN, IT WAS NOTICED THAT THE LOCKING MECHANISM WAS BROKEN. THE OFFSET BROACH HANDLE WAS USED INSTEAD WITH NO ADVERSE CONSEQUENCES. THIS WAS NOTICED DURING SET UP/INSPECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551634 SL-PLUS/SBG/IPA MIA OFFSET ADAPTER 10MM PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI SMITH & NEPHEW ORTHOPAEDICS AG 75007309 E59830 07611996076394

    Patients

    Seq Age Sex Outcome Treatment
    1