BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDON STRIPPER SLOTTED

    MDR report key: 9895111 · Received March 29, 2020

    Report

    Report Number
    1219602-2020-00562
    Event Type
    Malfunction
    Date Received
    March 29, 2020
    Date of Event
    March 3, 2020
    Report Date
    June 16, 2020
    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 USED IN TREATMENT, WAS RETURNED FOR EVALUATION. INSTRUCTION FOR USE CONTAINS PRECAUTIONARY STATEMENTS AND RECOMMENDATIONS FOR PROPER USE OF PRODUCT. THIS IS A ONE YEAR OLD REUSABLE INSTRUMENT. THE ALLEGATION WAS CONFIRMED. THE STRIPPER SPIRAL IS FRACTURED ACROSS THE ENTIRE BAND. THERE IS STAINING ON THE FRACTURED EDGE INDICATING THAT THE SPIRAL AREA LIKELY HAD AN EXISTING HAIRLINE FRACTURE PRIOR TO THE BREAK IN THIS CASE. THERE IS A DEGREE OF FLARE AND DISTORTION AT THE BREAK EDGE. THERE ARE SCRATCHES AND DINGS. PER INSTRUCTION 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.¿ COMPLAINT HISTORY REVIEW INDICATED A SIMILAR ALLEGATION FOR THE LOT NUMBER REPORTED. BATCH REVIEW DID NOT INDICATE A CONDITION, PRODUCT OR PROCEDURE FAILURE THAT SUPPORTED THE ALLEGATION. NO ROOT CAUSE RELATED TO THE MANUFACTURE OF THE DEVICE WAS CONFIRMED. PRODUCT MET SPECIFICATIONS UPON RELEASE TO DISTRIBUTION.

    Additional Manufacturer Narrative · 0

    H3, H6: ONE 013554 SLOTTED TENDON STRIPPER DEVICE WAS USED FOR TREATMENT BUT WAS NOT RETURNED FOR EVALUATION. INSTRUCTION FOR USE CONTAINS PRECAUTIONARY STATEMENTS AND RECOMMENDATIONS FOR PROPER USE OF PRODUCT. DUE TO PRODUCT UNAVAILABILITY, EVALUATION WAS LIMITED. IF FURTHER INFORMATION BECOMES AVAILABLE, THE COMPLAINT CAN CERTAINLY BE REVISITED. PER INSTRUCTION FOR USE: 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 FAILURE. THESE INSTRUMENTS ARE DESIGNED FOR REPEATED USE WITH PROPER CARE AND HANDLING. COMPLAINT HISTORY REVIEW INDICATED NO SIMILAR ALLEGATIONS FOR THE LOT NUMBER REPORTED. BATCH REVIEW DID NOT INDICATE A CONDITION, PRODUCT OR PROCEDURE FAILURE THAT SUPPORTED THE ALLEGATION. PRODUCT MET SPECIFICATIONS UPON RELEASE TO DISTRIBUTION.

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY, WHILE TAKING THE GRAFT (THE PATIENT¿S PERITONEAL LIGAMENT), THE DOCTOR REMOVED THE STRIPPER FROM THE PLACE WHERE THE LIGAMENT WAS TAKEN AND DISCOVERED THE ABSENCE OF A STRIPPER'S PIECE. AN EXTRA INCISION WAS IMMEDIATELY NEEDED TO EXTRACT THE PIECE, IT WAS REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358868 TENDON STRIPPER SLOTTED ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH SMITH & NEPHEW, INC. 013554 50802706 03596010091093

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR