BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO. MALLET 2 LB/ 1 LB

    MDR report key: 13632755 · Received March 1, 2022

    Report

    Report Number
    3011137372-2022-00037
    Event Type
    Malfunction
    Date Received
    March 1, 2022
    Date of Event
    February 16, 2022
    Report Date
    February 21, 2022
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    HXL
    UDI-DI
    24026704272222
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Additional Manufacturer Narrative · 0

    (B)(4). THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Additional Manufacturer Narrative · 0

    QN# (B)(4). DEVICE HISTORY RECORD WAS REVIEWED FOR NOTIFICATIONS PERTAINING TO INCOMING INSPECTION, STOCK CHECKS, AND PRODUCT RETURNS. NO CONCERNS WERE NOTED WITH REFERENCE TO KM68834. (1) SAMPLE OF KM69834 LOT B9 (FEB 2019) WAS RECEIVED FOR EVALUATION WITH A BROKEN PLUG EXTRACTOR. THE PLUG EXTRACTOR IS USED TO CLEAR THE INNER CANNULA AFTER A PLUG HAS BEEN CUT OUTSIDE OF THE SURGICAL FIELD. THE WELDED SEAM BETWEEN THE PLUG EXTRACTOR HANDLE AND SHAFT HAS SEPARATED. VISUAL INSPECTION OF THE HANDLE NOTED AN IMPACT MARK TO MATCHES THE PLUG CUTTER ORIFICE. THIS IMPACT LIKELY CONTRIBUTED TO THE BROKEN DEVICE. THE PLUG CUTTER IS STILL FUNCTIONAL BUT THE HANDLE FOR THE PLUG REMOVER HINDERS REMOVAL OF A CUT PLUG. ISOLATED INCIDENT WITH NO RISK TO THE PATIENT. (1) SAMPLE OF KM69834 LOT B9 (FEB 2019) WAS RECEIVED FOR EVALUATION WITH A BROKEN PLUG EXTRACTOR. THE PLUG EXTRACTOR IS USED TO CLEAR THE INNER CANNULA AFTER A PLUG HAS BEEN CUT OUTSIDE OF THE SURGICAL FIELD. THE WELDED SEAM BETWEEN THE PLUG EXTRACTOR HANDLE AND SHAFT HAS SEPARATED. VISUAL INSPECTION OF THE HANDLE NOTED AN IMPACT MARK TO MATCHES THE PLUG CUTTER ORIFICE. THIS IMPACT LIKELY CONTRIBUTED TO THE BROKEN DEVICE. A DIMENSIONAL INSPECTION WAS NOT REQUIRED AS PART OF THIS INVESTIGATION. THE PLUG CUTTER IS STILL FUNCTIONAL BUT THE HANDLE FOR THE PLUG REMOVER HINDERS REMOVAL OF A CUT PLUG. THERE ARE NO OTHER COMPLAINTS FOR THIS PRODUCT IN THE HISTORY OF SAP DATING BACK TO 2007. NO CONFIRMED COMPLAINTS WERE RECEIVED IN THIS RANGE WITH THE SAME ISSUE FOR THE PRODUCT FAMILY. DEVICE HISTORY RECORD WAS REVIEWED FOR NOTIFICATIONS PERTAINING TO INCOMING INSPECTION, STOCK CHECKS, AND PRODUCT RETURNS. NO CONCERNS WERE NOTED WITH REFERENCE TO KM68834. ISOLATED INCIDENT WITH NO RISK TO THE PATIENT.

    Description of Event or Problem · 0

    INSTRUMENT BROKE DURING PROCEDURE WHILE BEING USED.

    Description of Event or Problem · 0

    INSTRUMENT BROKE DURING PROCEDURE WHILE BEING USED.

    Description of Event or Problem · 0

    INSTRUMENT BROKE DURING PROCEDURE WHILE BEING USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1940426 ORTHO. MALLET 2 LB/ 1 LB MALLET HXL TELEFLEX MEDICAL IPN013965 UNKNOWN 24026704272222

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown