BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CABLE 4M TO CONSOLE FOR ELECTRIC PEN DRIVE

    MDR report key: 3031175 · Received April 2, 2013

    Report

    Report Number
    8030965-2013-10647
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    October 10, 2011
    Report Date
    October 10, 2011
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWE
    PMA / PMN Number
    K043310
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. ADDITIONAL NARRATIVE: THE ORIGINAL REPORT INCLUDED INCORRECT INFORMATION AND THE HOSPITAL CONFIRMED THE CORRECT PART # IS 05.001.021; HOWEVER, THE REPORTED LOT # IS NOT A VALID LOT # FOR THE UPDATED PART. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. BOTH DEVICES WERE RECEIVED FOR A MANUFACTURING EVALUATION AND BOTH ITEMS WERE DAMAGED. THE CUSTOMER COMPLAINT WAS VERIFIED AND ITEM WAS SCRAPPED (WORN OUT PARTS). IT IS IMPOSSIBLE TO DETERMINE HOW THE PRODUCT WAS HANDLED AND CLEANED OUT IN THE FIELD; THEREFORE, THIS COMPLAINT IS INDETERMINATE FROM A MANUFACTURING STANDPOINT.

    Additional Manufacturer Narrative · 1

    DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. ADDITIONAL PRODUCT CODE(S) FOR THIS REPORT INCLUDE, DZI, ERL, HBE. THIS REPORTED DEVICE IS SINGLE USE.

    Description of Event or Problem · 1

    THIS IS REPORT 2 OF 2 FOR THIS COMPLAINT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE FOOT SWITCH PEDAL IS REMOVED FROM THE SWITCH, THE DRILL CONTINUES TO RUN. THE CABLE FOR THE FOOT SWITCH HAS ALSO BEEN INCLUDED AS A POSSIBLE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134915 CABLE 4M TO CONSOLE FOR ELECTRIC PEN DRIVE HWE SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1