BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAGITTAL SAW ATTACHMENT

    MDR report key: 4163557 · Received October 10, 2014

    Report

    Report Number
    2520274-2014-14064
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    September 14, 2014
    Report Date
    September 18, 2014
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HWE
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER LOCATION WAS DOCUMENTED AS UNKNOWN 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 PREVIOUS REPORT STATED THE DATE OF MANUFACTURE (DOM) WAS UNKNOWN. IT HAS BEEN UPDATED TO REFLECT THE DATE THE DEVICE WAS MANUFACTURED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND THE REPORTED CONDITION COULD NOT BE 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.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING LOCATION WAS UNKNOWN. (B)(6). DEVICE MANUFACTURE DATE: THE DEVICE MANUFACTURE DATE IS UNAVAILABLE. THE ACTUAL DEVICE WAS RETURNED AND IS CURRENTLY PENDING EVALUATION. ONCE RELIABILITY ENGINEERING EVALUATES THE DEVICE, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED. 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 AN OPEN REDUCTION INTERNAL FIXATION (ORIF) DISTAL SURGICAL PROCEDURE, IT WAS DISCOVERED THAT THE ATTACHMENT DEVICE NEEDED A NEW SEAL. THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE AS AN IDENTICAL SPARE DEVICE WAS AVAILABLE FOR USE. 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
    639339 SAGITTAL SAW ATTACHMENT INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT HWE DEPUY SYNTHES POWER TOOLS 11992

    Patients

    Seq Age Sex Outcome Treatment
    1