BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO. MALLET 2 LB/ 1 LB

    MDR report key: 12342100 · Received August 19, 2021

    Report

    Report Number
    3011137372-2021-00220
    Event Type
    Malfunction
    Date Received
    August 19, 2021
    Date of Event
    June 8, 2021
    Report Date
    August 4, 2021
    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

    QN#(B)(4). (1) SAMPLE OF KM46666 LOT F9 (JULY 2019) WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION OF THE MALLET FACES SHOWS HEAVY WEAR ON THE HANDLE SIDE OF THE MALLET FACE FROM OFF CENTER IMPACT. THE FACE OF THE MALLET HAS ROLLED OVER THE EDGE AND EIBITS DEEP CRACKS AND SPLITS AROUND THE EXPANDED METAL. THE VISUAL APPEARANCE OF THIS DEVICE SHOULD HAVE REMOVED IT FROM USE BEFORE THIS LEVEL OF DAMAGE OCCURRED. DEVICE HISTORY RECORD WAS REVIEWED FOR NOTIFICATIONS PERTAINING TO INCOMING INSPECTION, STOCK CHECKS, AND PRODUCT RETURNS. NO CONCERNS WERE NOTED WITH REFERENCE TO KM46666. MALLET HEAD IS MADE OF A 300 SERIES "DEFORMABLE" STAINLESS STEEL. THIS MATERIAL IS NOT HARDENABLE WHICH IS INTENTIONAL. PRECIPITATION HARDENED STEELS CAN POTENTIALLY EXPLODE ON HEAVY IMPACT CREATING EXTREME RISK TO PATIENTS AND PHYSICIANS. ALL TELEFLEX INSTRUMENT IFUS FOR REUSEABLE DEVICES REQUIRE INSPECTION FOR CRACKS AND OTHER DEFECTS PRIOR TO USE AND CLEARLY SPECIFIES REMOVAL FROM SERVICE. THE SAMPLES RECEIVED FROM THIS CUSTOMER EXHIBIT HEAVY WEAR AND OFF CENTER STRIKING. DESPITE THE EXCESSIVE WEAR THE HANDLE UNION REMAINS INTACT FOR THIS DEVICE. ADDITIONAL COMPLAINTS FROM THE SAME CUSTOMER: CUSTOMER HAVE EXHIBITED DETACHED MALLET HEADS POST DEFORMATION OF THE MALLET FACE SHOWING REPEATED AND CONTINUED USE AGAINST IFU ADVISEMENTS. (1) SAMPLE OF KM46666 LOT F9 (JULY 2019) WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION OF THE MALLET FACES SHOWS HEAVY WEAR ON THE HANDLE SIDE OF THE MALLET FACE FROM OFF CENTER IMPACT. THE FACE OF THE MALLET HAS ROLLED OVER THE EDGE AND EIBITS DEEP CRACKS AND SPLITS AROUND THE EXPANDED METAL. THE VISUAL APPEARANCE OF THIS DEVICE SHOULD HAVE REMOVED IT FROM USE BEFORE THIS LEVEL OF DAMAGE OCCURRED. A DIMENSIONAL INSPECTION WAS NOT REQUIRED AS PART OF THIS INVESTIGATION. A FUNCTIONAL INSPECTION WAS NOT REQUIRED AS PART OF THIS INVESTIGATION. PREVIOUS COMPLAINTS INCLUDE (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 KM46666 THE SAMPLES RECEIVED FROM THIS CUSTOMER EXHIBIT HEAVY WEAR AND OFF CENTER STRIKING. DESPITE THE EXCESSIVE WEAR THE HANDLE UNION REMAINS INTACT FOR THIS DEVICE. ADDITIONAL COMPLAINTS FROM THE SAME CUSTOMER: CUSTOMER HAVE EXHIBITED DETACHED MALLET HEADS POST DEFORMATION OF THE MALLET FACE SHOWING REPEATED AND CONTINUED USE AGAINST IFU ADVISEMENTS. MALLET HEAD IS MADE OF A 300 SERIES "DEFORMABLE" STAINLESS STEEL. THIS MATERIAL IS NOT HARDENABLE WHICH IS INTENTIONAL. PRECIPITATION HARDENED STEELS CAN POTENTIALLY EXPLODE ON HEAVY IMPACT CREATING EXTREME RISK TO PATIENTS AND PHYSICIANS. ALL TELEFLEX INSTRUMENT IFUS FOR REUSEABLE DEVICES REQUIRE INSPECTION FOR CRACKS AND OTHER DEFECTS PRIOR TO USE AND CLEARLY SPECIFIES REMOVAL FROM SERVICE.

    Description of Event or Problem · 0

    INSTRUMENT DAMAGED DUE TO POOR QUALITY. MALLET HEADS HAVE DEFORMED SHAPE. FURTHER 2 OF THESE HAVE ACTUALLY BROKEN FROM THE STEM, ONE HAPPENED IN THEATRE WHICH IS VERY DANGEROUS TO STAFF AND PATIENT IF ACTUALLY IT HIT SOMEONE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE INVESTIGATION IS PENDING. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Description of Event or Problem · 1

    INSTRUMENT DAMAGED DUE TO POOR QUALITY. MALLET HEADS HAVE DEFORMED SHAPE. FURTHER 2 OF THESE HAVE ACTUALLY BROKEN FROM THE STEM, ONE HAPPENED IN THEATRE WHICH IS VERY DANGEROUS TO STAFF AND PATIENT IF ACTUALLY IT HIT SOMEONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1241817 ORTHO. MALLET 2 LB/ 1 LB MALLET HXL TELEFLEX MEDICAL IPN013965 F9 24026704272222

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown