BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDON STRIPPER SLOTTED

    MDR report key: 8816254 · Received July 23, 2019

    Report

    Report Number
    1219602-2019-00858
    Event Type
    Malfunction
    Date Received
    July 23, 2019
    Date of Event
    July 9, 2019
    Report Date
    August 27, 2019
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    LXH
    UDI-DI
    03596010091093
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ONE 013554 SLOTTED TENDON STRIPPER DEVICE WAS USED FOR TREATMENT AND RETURNED FOR EVALUATION. THIS IS A TWO YEAR OLD REUSABLE INSTRUMENT. THE COMPLAINT STATED: ¿DURING THE MANIPULATION TO PICK UP THE TENDON IN THE PATIENT'S BODY, THE STRIPPER TIP OF ABOUT 0.5 CM BROKE OFF.¿ THIS ALLEGATION WAS CONFIRMED. ONE SPIRAL IS FRACTURED ACROSS THE ENTIRE CONFIGURATION. THERE IS BIO MATTER AND STAINING APPARENT ON THE FRACTURED EDGE. STAINING INDICATES THAT THE STRIPPER CURL MAY HAVE HAD A HAIRLINE FRACTURE PRIOR TO THE BREAK REPORTED HERE. THERE IS A CREASE LINE WHERE POTENTIAL FOR A SECOND FRACTURE WAS NOTED. THERE A BOW OVER THE LENGTH OF THE SHAFT. THE SHAFT IS BENT SLIGHTLY DOWNWARD FROM THE HANDLE. PER INSTRUCTIONS FOR USE: ¿THESE INSTRUMENTS ARE DESIGNED FOR REPEATED USE WITH PROPER CARE AND HANDLING. 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. DO NOT USE THESE INSTRUMENTS AS LEVERS FOR MANIPULATING HARD TISSUE OR BONE. EXCESSIVE FORCE SHOULD NOT BE APPLIED TO THE INSTRUMENT WHEN MANIPULATING SOFT TISSUE, BONE, OR HARD OBJECTS. MISUSE OF THESE INSTRUMENTS MAY RESULT IN BENT DISTAL TIPS OR JAWS; AND DULL OR UNEVEN CUTTING EDGES.¿ NO ROOT CAUSE RELATED TO THE MANUFACTURE OF THE DEVICE WAS CONFIRMED. PRODUCT MET SPECIFICATIONS UPON RELEASE TO DISTRIBUTION.

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE MANIPULATION TO PICK UP THE TENDON IN THE PATIENT'S BODY, THE STRIPPER TIP OF ABOUT 0.5 CM BROKE OFF. THE BROKEN OFF PART WAS NOT REMOVED. THE PATIENT FEELS FINE. AN ADDITIONAL TOOL REMOVAL OPERATION IS NOT PLANNED. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO DELAY OR PATIENT INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610175 TENDON STRIPPER SLOTTED ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH SMITH & NEPHEW, INC. 50668292 03596010091093

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR