BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACL ACC DISPOSABLES KIT *EA

    MDR report key: 8301187 · Received February 4, 2019

    Report

    Report Number
    1221934-2019-56309
    Event Type
    Injury
    Date Received
    February 4, 2019
    Date of Event
    January 7, 2019
    Report Date
    January 7, 2019
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    LXH
    UDI-DI
    10886705011117
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. INVESTIGATION SUMMARY: THE COMPLAINT DEVICE IS NOT BEING RETURNED, IT WAS DISCARDED BY THE CUSTOMER, THEREFORE UNAVAILABLE FOR A PHYSICAL EVALUATION. HENCE, THIS COMPLAINT CANNOT BE CONFIRMED. NO FURTHER INFORMATION REGARDING THE TECHNIQUE OR INSTRUMENTS USED HAS BEEN PROVIDED TO DETERMINE A ROOT CAUSE FOR THIS FAILURE. IF ANY ADDITIONAL INFORMATION IS OBTAINED, THIS COMPLAINT WILL BE RE-OPENED TO CAPTURE THAT INFORMATION. FURTHERMORE, A NON-CONFORMANCE SEARCH WAS CONDUCTED AND NO NON-CONFORMANCES WERE IDENTIFIED FOR THIS PART NUMBER (232300), LOT NUMBER (L746310) COMBINATION. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED, AND NO FURTHER ACTION IS WARRANTED. HOWEVER, DEPUY SYNTHES MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REP VIA PHONE THAT FOLLOWING AN ACL RECONSTRUCTION PROCEDURE DURING THE POST-OPT X-RAY, IT WAS NOTICED THAT THE SALES REP'S ACL DISPOSABLE KIT GUIDE WIRE TIP BROKE OFF IN THE PATIENT DURING THE CASE. THE SALES REP STATED THAT THERE IS APPROXIMATELY A 15MM PIECE OF THE GUIDE WIRE IN THE PATIENT'S FEMUR. THE CASE WAS COMPLETED WITH THIS KIT WITH NO TIME DELAY. THE SALES REP STATED THERE IS NO PLAN FOR SURGICAL INTERVENTION. THE GUIDE WIRE TIP REMAINS IN THE PATIENT, WHILE THE REMAINDER OF THE ACL DISPOSABLE KIT WAS DISCARDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95935 ACL ACC DISPOSABLES KIT *EA ORTHOPAEDIC SURGICAL PROCEDURE KIT, NON-MEDICATED, SINGLE-USE LXH DEPUY MITEK LLC US L746310 10886705011117

    Patients

    Seq Age Sex Outcome Treatment
    1