BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THD SLIDE ONE

    MDR report key: 10849910 · Received November 17, 2020

    Report

    Report Number
    3006680097-2020-00003
    Event Type
    Malfunction
    Date Received
    November 17, 2020
    Date of Event
    October 14, 2020
    Report Date
    November 10, 2020
    Manufacturer
    THD SPA
    Product Code
    JAF
    PMA / PMN Number
    K090009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DISPOSABLE NEEDLE HOLDER WAS RETURNED TO THD SPA ON 10/28/2020. FROM THE SPA INITIAL TECHNICAL INVESTIGATION, THE BREAKAGE IS COMPATIBLE WITH A DEFORMATION BREAK DUE TO A NON-UNIFORMITY OF THE WELD (I.E. INCLUSIONS, VACUUM, CRACK, COLD WELD, ETC) AT THE LEVEL OF THE BREAKING ZONE. THIS DEFORMATION CORRESPOND TO THE WELDING AREA. THIS DEFORMATION DETERMINES A REDUCED RESISTANCE TO NEEDLE HOLDER TIP BENDING PRODUCING BREAKAGE IF STRESSED. THIS TYPE OF DEFORMATION / INCLUSION IS NOT DETECTABLE DURING INCOMING CONTROLS. THE INVESTIGATION OF THE COMPLAINT WITH REFERENCE TO THE MANUFACTURING RECORDS FOUND THAT THE SUBJECT DEVICE WAS RELEASED CONFORM FOR DISTRIBUTION AND NO ANOMALIES WERE FOUND. COMPLAINTS TREND ANALYSIS FOUND ONLY ONE SIMILAR EVENT ON THE SAME DEVICE ON OVER (B)(4) DEVICES SOLD OVER YEARS; WITH REGARDS TO INVOLVED BATCH NUMBER 010819, WE DID NOT RECEIVED ANY OTHER COMPLAINT. MOREOVER NEEDLE HOLDER SUPPLIER CONFIRMED THAT NO OTHER SIMILAR EVENTS HAVE BEEN NOTIFIED UP TO DATE. WE THEREFORE CONSIDER THE EVENT AS A RARE AND ISOLATED PROBLEM COMPATIBLE WITH A MANUFACTURING DEFECT RELATED TO WELDING, NOT DETECTABLE DURING INCOMING CONTROLS. THE SPA RETURNED THE DISPOSABLE NEEDLE HOLDER TO THE SUPPLIER FOR A MORE DETAILED TECHNICAL INVESTIGATION AND FOR THE EVALUATION OF A MONITORING ACTION ON NEW DEVICES IN ORDER TO PREVENT THE RE-OCCURRENCE OF A SIMILAR EVENT (I.E. ESTABLISH SPECIFIC INCOMING CONTROLS, ETC). SHOULD WE GET FURTHER INFORMATION, ADDITIONAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING A T.H.D. INTERVENTION, THE DISPOSABLE NEEDLE HOLDER, PART OF THE THD SLIDE ONE KIT (REF. 710004), BROKE. THE NEEDLE HOLDER TIP SNAPPED OFF WHILE LOADING THE SUTURE NEEDLE OUTSIDE THE PATIENT, THEREFORE THE TREATMENT WAS TERMINATED WITH ANOTHER THD KIT WITHOUT ANY CONSEQUENCE FOR THE PATIENT.THE BROKEN PIECE, CAME OFF FROM THE NEEDLE HOLDER, HAS BEEN DISPOSED BY THE STAFF, WHILE THE REMAINING PORTION OF THE NEEDLE HOLDER IS AVAILABLE FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1322928 THD SLIDE ONE THD SLIDE ONE JAF THD SPA 710004 010819

    Patients

    Seq Age Sex Outcome Treatment
    1 Other