BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE RENEWAL REPROCESSED SCORPION NEEDLE

    MDR report key: 6102890 · Received November 15, 2016

    Report

    Report Number
    3032391-2016-00042
    Event Type
    Malfunction
    Date Received
    November 15, 2016
    Date of Event
    October 13, 2016
    Report Date
    November 15, 2016
    Manufacturer
    MEDLINE RENEWAL
    Product Code
    HWQ
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IN QUESTION WAS RETURNED TO MEDLINE RENEWAL FOR EVALUATION. UPON RECEIPT, MEDLINE RENEWAL CONFIRMED THE DEVICE HAD BEEN REPROCESSED. OUR EVALUATION CONFIRMED THE REPORT, HOWEVER THE TIP WAS NOT RETURNED FOR EVALUATION. OUR INVESTIGATION INCLUDED BOTH AN INSPECTION OF THE RETURNED DEVICE, AND A REVIEW OF THE DEVICE HISTORY RECORD (DHR). WE RECONFIRMED THAT ALL PROCESSES WERE CONDUCTED AS REQUIRED, AND THAT THE DEVICE MET INSPECTION AND REQUIREMENTS PRIOR TO PACKAGING AND RELEASE. UNFORTUNATELY, THE ROOT CAUSE OF THE DEVICE FAILURE IS UNKNOWN AT THIS TIME. PER THE DEVICE INSTRUCTIONS FOR USE (IFU), THE USE OF EXCESSIVE FORCE TO PASS THE NEEDLE THROUGH FIBROUS/CALCIFIC TISSUE, OR STRIKING BONE CAN CAUSE NEEDLE BREAKAGE AND PATIENT INJURY. THIS CAN BE AVOIDED BY REPOSITIONING THE NEEDLE PASS THROUGH A DIFFERENT AREA. THERE HAS BEEN NO REPORT OF ADVERSE PATIENT CONSEQUENCE AS A RESULT OF THE INCIDENT. HOWEVER, DUE TO THE SURGICAL INTERVENTION TO RETRIEVE THE TIP WHICH CAUSED A DELAY IN THE PROCEDURE, MEDLINE RENEWAL IS FILING THIS MEDWATCH REPORT.

    Description of Event or Problem · 1

    MEDLINE RENEWAL RECEIVED A REPORT INDICATING THAT THE TIP OF A REPROCESSED ARTHREX SUREFIRE SCORPION NEEDLE, MODEL AR-13991N, DETACHED DURING USE. THE TIP WAS RETRIEVED BY THE SURGEON. ANOTHER DEVICE WAS READILY AVAILABLE TO COMPLETE THE PROCEDURE; THEREFORE NO PATIENT HARM OR ADDITIONAL MEDICAL INTERVENTION WAS REPORTED AS A RESULT OF THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    753871 MEDLINE RENEWAL REPROCESSED SCORPION NEEDLE SUTURE PASSER HWQ MEDLINE RENEWAL AR-13991N 312381

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention