BEUDAMED
    FDA Adverse Event Injury Summary report: N

    R-LISTON CUTT FCPS 7-1/4 STR

    MDR report key: 7677633 · Received July 11, 2018

    Report

    Report Number
    2523190-2018-00084
    Event Type
    Injury
    Date Received
    July 11, 2018
    Date of Event
    August 3, 2015
    Report Date
    July 11, 2018
    Manufacturer
    INTEGRA YORK, PA INC.
    Product Code
    HTZ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED ON 12SEP2018 CONTAINED PICTURES OF THE DEVICE INVOLVED IN THE EVENT. IN THE PICTURES, THE PRODUCT ID OF THE DEVICE HAS BEEN IDENTIFIED AS 230-305 AND THE PRODUCT DESCRIPTION IS R-LISTON CUTT FCPS 7-1/4 STR. THE PICTURED JARIT BONE CUTTING FORCEP APPEARS USED WITH THE INSTRUMENT ENTIRELY INTACT. THE ARTIFACT IN THE PATIENT HAS NOT BEEN IDENTIFIED AS PART OF THIS INSTRUMENT.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION; THEREFORE THE FAILURE MODE COULD NOT BE CONFIRMED. THE ROOT CAUSE CANNOT BE DETERMINED DUE TO THE LACK OF INFORMATION RECEIVED TO PERFORM A COMPLETE INVESTIGATION. PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION.

    Description of Event or Problem · 0

    N/A.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE PLANT INVESTIGATION IS IN PROGRESS AND A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A LEGAL ALLEGATION THAT ON (B)(6) 2015, A PATIENT UNDERWENT A SURGICAL PROCEDURE AT A SURGERY CENTER FACILITY. THE EQUIPMENT THE DOCTOR UTILIZED FOR THE PROCEDURE WERE THE CONMED MICRO OSCILLATOR BLADE, CONMED HALL MICRO 100 OSCILLATING SAW, CONMED HALL SURGAIRTOME TWO DRILL, AND THE JARIT RUSKIN-LISTON BONE CUTTING FORCEPS. DURING THE PROCEDURE, METAL WAS LEFT WITHIN THE PATIENT'S FOOT. THE PATIENT, AS A RESULT, SUFFERED PAIN AND A DISABILITY REQUIRING THE PATIENT TO SEEK FURTHER UNSPECIFIED MEDICAL TREATMENT. NO SPECIFIC DEVICE IS INDICATED WITHIN THE PROVIDED DOCUMENT AS TO WHICH DEVICE BROKE AND REMAINED IN THE PATIENT'S FOOT. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521055 R-LISTON CUTT FCPS 7-1/4 STR CARDIOVASCULAR BONE HTZ INTEGRA YORK, PA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R CONMED HALL MICRO100 OSCILLATING SAW| CONMED HALL SURGAIRTOME TWO DRILL| CONMED MICROOSCILLATOR BLADE| CONMED HALL MICRO100 OSCILLATING SAW| CONMED HALL SURGAIRTOME TWO DRILL| CONMED MICROOSCILLATOR BLADE