BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTRIC PEN DRIVE 60,000 RPM

    MDR report key: 3831929 · Received May 27, 2014

    Report

    Report Number
    2520274-2014-00979
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Date of Event
    January 23, 2014
    Report Date
    May 20, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWE
    PMA / PMN Number
    K043310
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL PRODUCT CODE/S: DZI, ERL AND HBE. THE POWER DEVICE IS AN INSTRUMENT AND NOT IMPLANT/EXPLANTED. RECEIVED FACILITY QUESTIONNAIRE ON 5/20/2014 WHICH CHANGED THE NON-REPORTABLE STATUS TO A REPORTABLE CASE. THE SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. AN ADDITIONAL EVALUATION/SYNTHES POWER TOOL EVALUATION WAS CONDUCTED. THE REPORT STATED THE DEVICE CONDITION WAS RECEIVED AS BLEMISHED HOUSING. IT CONCLUDED: THE REPORTER'S COMPLAINT THAT THE UNIT DOES NOT FUNCTION WAS CONFIRMED. THE DEVICE WAS TESTED AND THE COMPLAINT WAS DUPLICATED. EVIDENCE INDICATES THIS IS DUE TO USAGE WEAR OVER TIME. THE INVESTIGATION IS ON-GOING. A SERVICE HISTORY REVIEW HAS BEEN REQUESTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.SERVICE HISTORY OF THE PAST SIX MONTHS FROM THE AWARENESS DATE WAS REVIEWED. NO SERVICE HISTORY REVIEW CAN BE PERFORMED. THE ITEM HAS NOT BEEN IN FOR SERVICE FOR THE PAST SIX MONTHS. THERE IS NO INFORMATION RELEVANT TO THE CURRENT COMPLAINED ISSUE.THE MANUFACTURE DATE OF THIS ITEM IS UNKNOWN.(B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED ON (B)(6) 2014 THAT THE HOSPITAL MATERIALS MANAGER ADVISED THE ELECTRIC PEN DRIVE 60,000 RPM (PART # 05.001.010; LOT # 5482) WOULD NOT WORK. NO REPORT OF HARM TO PATIENT OR PROCEDURE REPORTED. UPDATE - (B)(6) 2014: ADDITIONAL INFORMATION PROVIDED BY FACILITY SIGNED QUESTIONNAIRE. MATERIALS MANGER REPORTED: THE DATE OF EVENT IS (B)(6) 2014; THE SURGICAL TEAM OPENED ANOTHER E-PEN FOR AN UNKNOWN PROCEDURE AND SUCCESSFULLY FINISHED THE CASE WITH NO DELAY. THERE WAS NO REPORT OF HARM TO PATIENT. FACILITY ALSO REPORTED PATIENT ID, DOB AND GENDER. THIS REPORT IS FOR ONE POWER DEVICE. THIS IS 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311330 ELECTRIC PEN DRIVE 60,000 RPM HWE SYNTHES (USA) 5482

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR