BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RECIPROCATING SAW ATTACHMENT FOR TRS

    MDR report key: 3833944 · Received May 27, 2014

    Report

    Report Number
    2520274-2014-11526
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Date of Event
    May 6, 2014
    Report Date
    May 9, 2014
    Manufacturer
    N/I
    Product Code
    HWE
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURE FACILITY WAS UNKNOWN. THE DATE OF MANUFACTURE WAS UNKNOWN. THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE. THE DEVICE WAS TESTED AND THE REPORTED CONDITION WAS CONFIRMED. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO DAMAGED BALL BEARINGS FROM NORMAL USE OVER TIME. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TOTAL KNEE REVISION SURGICAL PROCEDURE, IT WAS DISCOVERED THAT THE RECIPROCATING SAW ATTACHMENT DEVICE WAS MAKING NOISE AND THEN STOPPED WORKING. THERE WAS A TEN MINUTE DELAY IN THE SURGICAL PROCEDURE AS A RESULT. A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311445 RECIPROCATING SAW ATTACHMENT FOR TRS INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT HWE N/I 2711

    Patients

    Seq Age Sex Outcome Treatment
    1