BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO. MALLET 2 LB/ 1 LB

    MDR report key: 9618036 · Received January 22, 2020

    Report

    Report Number
    3011137372-2020-00031
    Event Type
    Malfunction
    Date Received
    January 22, 2020
    Date of Event
    January 6, 2020
    Report Date
    January 17, 2020
    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 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. VISUAL REVIEW NOTED THAT THE MALLET HEAD HAS SEPARATED FROM THE HANDLE. THE FRACTURE PLANE INDICATES OFF CENTER STRIKING OF THE MALLET FACE. THE MALLET FACE EXHIBITS SEVERE DEFORMATION AROUND THE PROXIMAL EDGE WHERE THE EDGE OF THE MALLET HAS REPEATEDLY BEEN STRUCK. ISOLATED INCIDENT RELATED TO METHOD OF USE. (1) SAMPLE OF KM46666 LOT E6 WAS RECEIVED FOR EVALUATION. VISUAL REVIEW NOTED THAT THE MALLET HEAD HAS SEPARATED FROM THE HANDLE. THE FRACTURE PLANE INDICATES OFF CENTER STRIKING OF THE MALLET FACE. THE MALLET FACE EXHIBITS SEVERE DEFORMATION AROUND THE PROXIMAL EDGE WHERE THE EDGE OF THE MALLET HAS REPEATEDLY BEEN STRUCK. A DIMENSIONAL INSPECTION WAS NOT REQUIRED AS PART OF THIS INVESTIGATION. A FUNCTIONAL INSPECTION WAS NOT REQUIRED AS PART OF THIS INVESTIGATION. (B)(4) & (B)(4) - BOTH WERE RETURNED IN A HEAVILY DEFORMED STATE SAP WAS REVIEWED FOR NOTIFICATIONS PERTAINING TO INCOMING INSPECTION, STOCK CHECKS, AND PRODUCT RETURNS. NO CONCERNS WERE NOTED WITH REFERENCE TO KM46666 ISOLATED INCIDENT RELATED TO METHOD OF USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SURGEON WAS PERFORMING A RIGHT TOTAL KNEE REPLACEMENT AND USING THE MALLET TO INSERT THE PROSTHESIS (USUAL PRACTICE) THE HEAD OF THE MALLET FLEW OFF; DETACHED FROM THE HANDLE AND LANDED ON THE FLOOR WHERE THE SCOUT NURSE HAD JUST PREVIOUSLY BEEN STANDING.

    Additional Manufacturer Narrative · 1

    (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

    IT WAS REPORTED THAT THE SURGEON WAS PERFORMING A RIGHT TOTAL KNEE REPLACEMENT AND USING THE MALLET TO INSERT THE PROSTHESIS (USUAL PRACTICE) THE HEAD OF THE MALLET FLEW OFF; DETACHED FROM THE HANDLE AND LANDED ON THE FLOOR WHERE THE SCOUT NURSE HAD JUST PREVIOUSLY BEEN STANDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    80868 ORTHO. MALLET 2 LB/ 1 LB MALLET HXL TELEFLEX MEDICAL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1