BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELESCOPIC STRUT MEDIUM HOFFMANN LRF LENGTH: 138-201MM (BLUE)

    MDR report key: 3537383 · Received December 26, 2013

    Report

    Report Number
    0008031020-2013-00480
    Event Type
    Malfunction
    Date Received
    December 26, 2013
    Date of Event
    December 2, 2013
    Report Date
    December 2, 2013
    Manufacturer
    STRYKER TRAUMA SELZACH
    Product Code
    KTT
    PMA / PMN Number
    K113327
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE REPORTED EVENT THAT TELESCOPIC STRUT BREAKAGE COULD BE CONFIRMED. BASED ON INVESTIGATION, THE ROOT CAUSE OF THE DETERMINED BREAKAGE WAS ATTRIBUTED TO A USER RELATED ISSUE. THE BREAKAGE WAS CAUSED BY OVERLOADING. HOFFMANN LRF OPTECH (LITERATURE NUMBER : US-982373 REV. 2) "IT IS RECOMMENDED TO INSERT A MINIMUM OF 3 POINTS OF FIXATION PER CIRCULAR RING AND A MINIMUM OF 4 POINTS OF FIXATION PER FOOT RING. IF ONLY WIRES ARE USED ON A FIXATION BLOCK THEN 4 WIRES ARE RECOMMENDED. A MINIMUM OF 4 STRUTS IS RECOMMENDED FOR THIS APPLICATION. WARNING: TO ENSURE SUFFICIENT CONSTRUCT STABILITY, IT IS RECOMMENDED THAT THE TIBIAL RING AND FOOT ARCH ARE REINFORCED WITH SUPPLEMENTAL FIXATION. SHOWN: DISTAL TIBIAL RING AND FOOT ARCH BRIDGED WITH HINGED COUPLINGS AND THREADED ROD. IN CERTAIN INCIDENCES, SUPPLEMENTAL FIXATION SHOULD BE CONSIDERED (I.E. OBESE PATIENTS OR PATIENTS THAT ARE AMBULATORY IN THE EARLY POSTOPERATIVE PHASE). CONSTRUCT DESIGN AND WEIGHT BEARING PROTOCOLS ARE ALWAYS TO THE SURGEON¿S DISCRETION." [ORIGINAL STATEMENT] A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. INDICATIONS FOR ANY MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE NOT DETERMINED IN THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE REMOVING THE HOFFMAN LRF FRAME ONE OF THE TELESCOPIC STRUT WERE BROKEN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE REMOVING THE HOFFMAN LRF FRAME ONE OF THE TELESCOPIC STRUT WERE BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    676671 TELESCOPIC STRUT MEDIUM HOFFMANN LRF LENGTH: 138-201MM (BLUE) APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT KTT STRYKER TRAUMA SELZACH R13279

    Patients

    Seq Age Sex Outcome Treatment
    1 Other