BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.0CM SHORT ATTACHMENT

    MDR report key: 6676272 · Received June 29, 2017

    Report

    Report Number
    1045834-2017-11388
    Event Type
    Malfunction
    Date Received
    June 29, 2017
    Report Date
    May 29, 2017
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    K011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). 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. 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

    ADDITIONAL NARRATIVE: THIS DEVICE WAS RETURNED FOR SERVICE; HOWEVER, DID NOT MEET MANUFACTURING SPECIFICATIONS DURING PRE-REPAIR ASSESSMENT. DURING REPAIR, IT WAS DETERMINED THAT THE DEVICE HAD MISSING COMPONENTS- ROLL PINS. SPIRAL PIN HP-0033-02 AND SYMBOL WITH THE OTHER ONE HAS HIKED/CAME OUT. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR VISUAL ASSESSMENT. THEREFORE, THE REPORTED CONDITION WAS CONFIRMED. HOWEVER, SINCE THE INVESTIGATION IS STILL ON-GOING, THE ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED AT THIS TIME. ONCE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    CORRECTION: IT WAS DOCUMENTED IN THE PREVIOUS REPORT THAT THE REPORTED CONDITION WAS CONFIRMED. FURTHER EVALUATION DETERMINED THAT THE REPORTED CONDITION WAS NOT CONFIRMED. UPDATED DEVICE EVALUATION: THIS DEVICE WAS RETURNED FOR SERVICE; HOWEVER, DID NOT MEET MANUFACTURING SPECIFICATIONS DURING PRE-REPAIR ASSESSMENT. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND IDENTIFIED NO FAILURE AS THE DEVICE PASSED ALL OPERATIONAL SPECIFICATIONS. THEREFORE, THE REPORTED CONDITION WAS NOT CONFIRMED. AN ASSIGNABLE ROOT CAUSE WAS NOT DETERMINED. 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 FROM (B)(6) THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE ATTACHMENT DEVICE HAD MISSING COMPONENTS OF THE ROLL PINS, A SYMBOL (LABELING), AND A SPIRAL PIN. IT WAS ALSO NOTED THAT THE PART OF THE DEVICE HAS HIKED AND THE DEVICE CAME APART. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EVENT DATE WAS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456701 5.0CM SHORT ATTACHMENT MOTOR, DRILL, ELECTRIC - ATTACHMENT HBC DEPUY SYNTHES POWER TOOLS N/A

    Patients

    Seq Age Sex Outcome Treatment
    1