BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEM

    MDR report key: 3714758 · Received March 31, 2014

    Report

    Report Number
    3009450871-2014-10050
    Event Type
    Malfunction
    Date Received
    March 31, 2014
    Date of Event
    March 3, 2014
    Report Date
    March 3, 2014
    Manufacturer
    SYNTHES OBERDORF
    Product Code
    HWE
    PMA / PMN Number
    PK043310
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: CORRECTION: THE MANUFACTURER LOCATION WAS DOCUMENTED AS WALDENBURG IN THE INITIAL REPORT. THE LOCATION HAS BEEN UPDATED TO (B)(4). CONTACT OFFICE NAME/ADDRESS HAVE BEEN UPDATED ACCORDINGLY TO REFLECT THE CORRECTED MANUFACTURING FACILITY. THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION.  RELIABILITY ENGINEERING EVALUATED THE DEVICE AND THE REPORTED CONDITION WAS DUPLICATED AND CONFIRMED.  THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE NORMAL WEAR FROM USE AND SERVICING. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE HAS BEEN RETURNED AND IS CURRENTLY PENDING EVALUATION. ONCE RELIABILITY ENGINEERING EVALUATES THE DEVICE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING INSPECTION, THE MOTOR DEVICE DID ¿NOT WORK WITH ANY CONSOLE". THERE WAS NO PATIENT INVOLVEMENT. THE REPORTER STATED THAT THE EVENT DID NOT OCCUR DURING SURGERY AS THE EQUIPMENT WAS USED FOR DEMONSTRATION PURPOSES ONLY. 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
    189035 SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEM INSTR, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR/ACCESS & ATTACH HWE SYNTHES OBERDORF 1029

    Patients

    Seq Age Sex Outcome Treatment
    1 CONSOLE DEVICE