BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDON STRIPPER,SLOTTED

    MDR report key: 6599851 · Received May 30, 2017

    Report

    Report Number
    1219602-2017-00562
    Event Type
    Malfunction
    Date Received
    May 30, 2017
    Date of Event
    May 2, 2017
    Report Date
    July 24, 2017
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE INVESTIGATION NARRATIVE - ONE 013554 SLOTTED TENDON STRIPPER RETURNED. THIS IS A USED DEVICE. IT IS 10 YEARS OLD. THE PRODUCT WAS RECEIVED INTENTIONALLY DEFACED BY MUTILATION TO AVOID ACCIDENTAL REUSE. THE COMPLAINT WAS LISTED AS ¿BROKEN TIP¿. THIS ALLEGATION HAS BEEN CONFIRMED. ONE SPIRAL IS FRACTURED ACROSS THE ENTIRE CONFIGURATION. IT WAS NOTICED THAT THE OTHER SPIRAL ALSO HAS A SMALL CHIP MISSING. NEITHER BROKEN PIECES WERE RETURNED. PER IFU: ¿AS WITH ANY SURGICAL INSTRUMENT, CAREFUL ATTENTION SHOULD BE MADE TO ASSURE THAT EXCESSIVE FORCE IS NOT PLACED ON THE INSTRUMENT. EXCESSIVE FORCES APPLIED TO THE INSTRUMENT CAN RESULT IN THE INSTRUMENT¿S FAILURE¿. THESE DEVICES ARE NOT INTENDED TO BE USED AS A SOURCE OF LEVERAGE. NO ROOT CAUSE ASSOCIATED WITH THE MANUFACTURE OF THESE DEVICES COULD BE FOUND. (B)(4).

    Additional Manufacturer Narrative · 1

    EXAMINATION WAS NOT POSSIBLE, AS THE DEVICE WAS NOT RETURNED. THE INVESTIGATION WAS LIMITED TO THE INFORMATION PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT WITH THE CLINICAL DETAILS PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE DUE TO A LOT NUMBER NOT BEING PROVIDED. NO FURTHER INVESTIGATION IS WARRANTED AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE THE TIP OF THE SUTURE STRIPPER WAS NOTICED TO BE BROKEN OFF. RADIOGRAPHS CONFIRMED THE TIP WAS NOT IN THE PATIENT. NO DELAY OR PATIENT IMPACT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380781 TENDON STRIPPER,SLOTTED ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH SMITH & NEPHEW, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1