BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAGITTAL SAW ATTACHMENT

    MDR report key: 7108499 · Received December 12, 2017

    Report

    Report Number
    8030965-2017-50444
    Event Type
    Malfunction
    Date Received
    December 12, 2017
    Report Date
    November 16, 2017
    Manufacturer
    DEPUY SYNTHES PRODUCTS LLC
    Product Code
    HWE
    UDI-DI
    07611819107182
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE DEVICE RETURNED TO MANUFACTURER: THE DEVICE RETURNED DATE WAS INADVERTENTLY OMITTED FROM THE INITIAL REPORT. THE DATE HAS BEEN UPDATED AS 11/17/2017. THIS DEVICE WAS RETURNED FOR SERVICE; HOWEVER, DID NOT MEET MANUFACTURING SPECIFICATIONS DURING PRE-REPAIR ASSESSMENT. DURING REPAIR, IT WAS DETERMINED THAT THE REPORTED CONDITION WAS CONFIRMED. IT WAS DETERMINED THAT THE COUPLING TOOL SIDE WAS NOT FUNCTIONING AND DEFECTIVE. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO WEAR FROM NORMAL USE AND SERVICING. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    REPORTER'S FULL NAME AND COMPLETE ADDRESS WERE NOT PROVIDED. (B)(6). AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED. 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 THE ¿GOM¿ CAME OUT FROM DIAL OF THE SAGITTAL SAW ATTACHMENT DEVICE. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY. THERE WAS NO HUMAN PATIENT INVOLVEMENT AS THIS DEVICE IS ONLY USED FOR VETERINARY PROCEDURES. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE. IT WAS NOT REPORTED IF THERE WERE ANY INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THIS EVENT WAS UNKNOWN. 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
    887452 SAGITTAL SAW ATTACHMENT INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT HWE DEPUY SYNTHES PRODUCTS LLC N/A 07611819107182

    Patients

    Seq Age Sex Outcome Treatment
    1