BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO. MALLET 2 LB/ 1 LB

    MDR report key: 11088123 · Received December 29, 2020

    Report

    Report Number
    3011137372-2020-00299
    Event Type
    Malfunction
    Date Received
    December 29, 2020
    Date of Event
    December 28, 2020
    Report Date
    December 28, 2020
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    HXL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    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 F9 WAS RECEIVED FOR EVALUATION. THE MALLET HEAD HAS SEPARATED FROM THE HANDLE AS DESCRIBED. THE MALLET FACES ARE HEAVILY DEFORMED FROM EXCESSIVE STRIKING FORCE. THE HEAD HAS "MUSHROOMED" AND THE EDGES OF THE MALLET FACE ARE EXHIBITING STRESS CRACKS FROM THE EXPANSION. INSPECT THE INSTRUMENT FOR RUST, PITTING, CRACKING OR BURRS, STAINING OR DISCOLORATION, READABILITY OF DEVICE MARKINGS AS APPLICABLE AND WORN OR BROKEN PARTS. REPAIR OR REPLACE ANY INSTRUMENT FOUND NOT TO BE ACCEPTABLE. THE STATE OF THE MALLET FACES DEMONSTRATES THE EXCESSIVE FORCE THIS INSTRUMENT HAS ENDURED PRIOR TO FAILURE. THE CRACKING OF THE MALLET EDGES INDICATED THE NEED TO REMOVE FROM SERVICE AS INDICATED IN THE IFU POST CLEANING INSPECTION. (1) SAMPLE OF KM46666 LOT F9 WAS RECEIVED FOR EVALUATION. THE MALLET HEAD HAS SEPARATED FROM THE HANDLE AS DESCRIBED. THE MALLET FACES ARE HEAVILY DEFORMED FROM EXCESSIVE STRIKING FORCE. THE HEAD HAS "MUSHROOMED" AND THE EDGES OF THE MALLET FACE ARE EXHIBITING STRESS CRACKS FROM THE EXPANSION. A DIMENSIONAL INSPECTION WAS NOT REQUIRED AS PART OF THIS INVESTIGATION. A FUNCTIONAL INSPECTION WAS NOT REQUIRED AS PART OF THIS INVESTIGATION. A PREVIOUS COMPLAINT WAS RECEIVED FROM THE SAME CUSTOMER. 20037331 SAP WAS REVIEWED FOR NOTIFICATIONS PERTAINING TO INCOMING INSPECTION, STOCK CHECKS, AND PRODUCT RETURNS. NO CONCERNS WERE NOTED WITH REFERENCE TO KM46666. PER IFU- L02415 R01, INSPECT THE INSTRUMENT FOR RUST, PITTING, CRACKING OR BURRS, STAINING OR DISCOLORATION, READABILITY OF DEVICE MARKINGS AS APPLICABLE AND WORN OR BROKEN PARTS. REPAIR OR REPLACE ANY INSTRUMENT FOUND NOT TO BE ACCEPTABLE. THE STATE OF THE MALLET FACES DEMONSTRATES THE EXCESSIVE FORCE THIS INSTRUMENT HAS ENDURED PRIOR TO FAILURE. THE CRACKING OF THE MALLET EDGES INDICATED THE NEED TO REMOVE FROM SERVICE AS INDICATED IN THE IFU POST CLEANING INSPECTION.

    Description of Event or Problem · 0

    REPORTED ISSUE: WE HAD ANOTHER MALLET SHEAR - KM46-666. PATIENT WAS NOT HURT.

    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

    REPORTED ISSUE: WE HAD ANOTHER MALLET SHEAR - KM46-666. PATIENT WAS NOT HURT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1552352 ORTHO. MALLET 2 LB/ 1 LB MALLET HXL TELEFLEX MEDICAL NA

    Patients

    Seq Age Sex Outcome Treatment
    1