BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO. MALLET 2 LB/ 1 LB

    MDR report key: 12031670 · Received June 21, 2021

    Report

    Report Number
    1036844-2021-00126
    Event Type
    Malfunction
    Date Received
    June 21, 2021
    Date of Event
    June 8, 2021
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    HXL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    QN#(B)(4). DEVICE HISTORY RECORD (DHR)WAS REVIEWED FOR NOTIFICATIONS PERTAINING TO INCOMING INSPECTION, STOCK CHECKS, AND PRODUCT RETURNS. NO CONCERNS WERE NOTED WITH REFERENCE TO KM46666. (1) SAMPLE OF KM46666 LOT E6 WAS RECEIVED FOR EVALUATION. THE MALLET HEAD HAS SEPARATED FROM THE HANDLE. A FRACTURE IS EVIDENT AT THE UNION POINT. THE FRACTURE PLANE SUGGESTS OFF CENTER IMPACT. ADDITIONAL SAMPLES FROM THIS CUSTOMER INCLUDED A SEVERELY DEFORMED MALLET FACE WHERE THE FACE WAS STRUCK OFF CENTER WITH EXCESSIVE FORCE. THE FRACTURE PLANE OF THIS DEVICE ALSO SUGGESTS AN OFF-CENTER IMPACT. (1) SAMPLE OF KM46666 LOT E6 WAS RECEIVED FOR EVALUATION. THE MALLET HEAD HAS SEPARATED FROM THE HANDLE. A FRACTURE IS EVIDENT AT THE UNION POINT. THE FRACTURE PLANE SUGGESTS OFF CENTER IMPACT. A DIMENSIONAL INSPECTION WAS NOT REQUIRED AS PART OF THIS INVESTIGATION. THE DEVICE IS NOT FUNCTIONAL IN THE CURRENT STATE. DUE TO THE NATURE OF USAGE, THIS DEVICE EXPERIENCES REPEATED STRIKING IMPACT AND IS SUBJECT TO PREMATURE WEAR WHEN FORCES ARE EXCESSIVE. GIVEN THE AGE OF THE DEVICE THIS APPEARANCE WOULD BE CONSIDERED NORMAL. INSTRUMENT INSPECTION SHOULD REMOVE THESE INSTRUMENTS FORM USE AT THE FIRST SIGNS OF DEGRADATION WHICH HAVE BEEN PRESENT FOR SOME TIME. SIMILAR COMPLAINTS INCLUDE - (B)(4). DEVICE HISTORY RECORD (DHR)WAS REVIEWED FOR NOTIFICATIONS PERTAINING TO INCOMING INSPECTION, STOCK CHECKS, AND PRODUCT RETURNS. NO CONCERNS WERE NOTED WITH REFERENCE TO KM46666. ADDITIONAL SAMPLES FROM THIS CUSTOMER INCLUDED A SEVERELY DEFORMED MALLET FACE WHERE THE FACE WAS STRUCK OFF CENTER WITH EXCESSIVE FORCE. THE FRACTURE PLANE OF THIS DEVICE ALSO SUGGESTS AN OFF-CENTER IMPACT.

    Additional Manufacturer Narrative · 0

    QN#(B)(4). A VISUAL INSPECTION OF THE PRODUCT INVOLVED IN THE COMPLAINT COULD NOT BE CONDUCTED SINCE THE PRODUCT WAS NOT RETURNED. NO PHOTOS WERE PROVIDED. A FUNCTIONAL INSPECTION WAS NOT REQUIRED AS PART OF THIS INVESTIGATION. THE MALLET FACE IS INTENTIONALLY MADE OF 300 SERIES STAINLESS TO PREVENT SPONTANEOUS FAILURE. EXCESSIVE USE OF FORCE WILL DEFORM THE MALLET HEAD PREMATURELY. A VISUAL INSPECTION OF THE PRODUCT INVOLVED IN THE COMPLAINT COULD NOT BE CONDUCTED SINCE THE PRODUCT WAS NOT RETURNED. NO PHOTOS WERE PROVIDED. A DIMENSIONAL INSPECTION WAS NOT REQUIRED AS PART OF THIS INVESTIGATION. A FUNCTIONAL INSPECTION WAS NOT REQUIRED AS PART OF THIS INVESTIGATION. ALL PREVIOUSLY RECEIVED SAMPLES EXHIBITED EXCESSIVE DEFORMATION AND CRACKING AROUND THE MALLET FACE. THE MATERIAL OF THE MALLET FACE IS 300 STAINLESS STEEL WHICH IS NOT HARDENABLE. THESE DEVICES SHOULD HAVE BEEN REMOVED FROM SERVICE AT THE FIRST SIGNS OF DEGRADATION.

    Additional Manufacturer Narrative · 1

    QN# (B)(4). THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION. 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
    928795 ORTHO. MALLET 2 LB/ 1 LB MALLET HXL TELEFLEX MEDICAL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1