BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHORELINE ACS

    MDR report key: 21127982 · Received January 10, 2025

    Report

    Report Number
    3012120772-2025-00003
    Event Type
    Malfunction
    Date Received
    January 10, 2025
    Date of Event
    November 27, 2024
    Report Date
    February 25, 2025
    Manufacturer
    SEASPINE ORTHOPEDICS CORPORATION
    Product Code
    MAX
    UDI-DI
    10889981126889
    PMA / PMN Number
    K240830
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATE TO H3: DEVICE EVALUATED BY MANUFACTURER CHANGED TO "YES". INVESTIGATION CONCLUSION: THE RETURNED INSERTER INSTRUMENT WAS VISUALLY INSPECTED TO CONFIRM THE FAILURE MODE OUTLINED IN THE DESCRIPTION OF THE COMPLAINT. AFTER REVIEWING THE INSTRUMENT, IT WAS CONFIRMED THAT THE TIP OF THE INNER DRAW ROD SHEARED OFF FROM THE COMPONENT. THE LOCATION OF THE BREAK OCCURRED RIGHT AT THE POINT WHERE THE INNER DRAW ROD IS EXPOSED PAST THE OUTER SLEEVE LOCATING TIPS. ANOTHER OBSERVATION FOUND DURING THE VISUAL INSPECTION WAS THAT THE DRAW ROD EXPERIENCED MORE RESISTANCE THAN NORMAL WHILE MOVING THROUGH THE INTERNAL THREADED REGION OF THE SLEEVE. UPON FURTHER REVIEW, IT WAS DETERMINED THAT THE BOTTOM THREAD START WAS PARTIALLY DEFORMED. ALSO, IT SHOULD BE NOTED THAT THE RETURNED INSERTER WAS MARKED AS 86-0010, BUT THE RETURNED INNER DRAW ROD COMPONENT WAS 86-0011-20. 86-0011-20 IN THE INNER DRAW ROD INTENDED FOR THE INSERTER VERSION THAT INCLUDES A DEPTH STOP. ROOT CAUSE: THE REPORTED COMPLAINT MAY BE DUE TO MISUSE, SURGICAL TECHNIQUE, OR EXCESSIVE TORSIONAL FORCE. THESE DEVICES ARE PART OF LOANER SETS THAT ARE SUBJECT TO HANDLING AND REPEAT USE AFTER DISTRIBUTION. WEAR AND DAMAGE CAN OCCUR OVER TIME. EXACT ROOT CAUSE UNABLE TO BE DETERMINED. REVIEW OF LABELING: INTRAOPERATIVE WARNINGS BREAKAGE, SLIPPAGE, OR MISUSE OF INSTRUMENTS OR IMPLANT COMPONENTS MAY CAUSE INJURY TO THE PATIENT OR OPERATIVE PERSONNEL.

    Additional Manufacturer Narrative · 0

    H3: INSTRUMENT HAS BEEN RETURNED, BUT OUTCOME OF THE INVESTIGATION IS STILL PENDING. REVIEW OF LABELING: INTRAOPERATIVE WARNINGS: BREAKAGE, SLIPPAGE, OR MISUSE OF INSTRUMENTS OR IMPLANT COMPONENTS MAY CAUSE INJURY TO THE PATIENT OR OPERATIVE PERSONNEL.

    Description of Event or Problem · 0

    THE SURGEON REPORTED THE TIP OF THE SHORELINE ACS INSERTER BROKE WHILE PERFORMING SURGERY ON (B)(6) 2024. THE DISTAL TIP OF THE INSERTER WAS LEFT IN THE PATIENT. CUSTOMER CONFIRMS THERE WAS NO PATIENT INJURY, NO DELAY IN SURGERY AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THE ISSUE DID NOT REQUIRE ADDITIONAL MEDICAL OR SURGICAL TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499926 SHORELINE ACS INSERTER MAX SEASPINE ORTHOPEDICS CORPORATION 86-0010 AL652047G 10889981126889

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other