BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RECON SAGITTAL SAW WITH KEY FOR TRAUMA RECON SYSTEM

    MDR report key: 6013827 · Received October 10, 2016

    Report

    Report Number
    8030965-2016-15049
    Event Type
    Injury
    Date Received
    October 10, 2016
    Report Date
    September 17, 2016
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    GEY
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UDI: THE SERIAL NUMBER IS UNKNOWN AND THE GTIN IS UNAVAILABLE. THE PRODUCT WAS MADE PRIOR TO COMPLIANCE DATE. THEREFORE, UDI IS UNAVAILABLE. (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 DURING UNSPECIFIED SURGICAL PROCEDURES, IT WAS DISCOVERED THAT THE RECON SAGITTAL SAW DEVICES WERE TOO LOUD. IT WAS REPORTED THAT DURING A WET LAB, THE SURGEON EXPLAINED THAT THE MEASURED NOISE WAS ABOVE THE LEVEL OF ~80DB, WHICH WAS ABOVE THE LEGAL SPECIFICATION. THE SURGEON FURTHER STATED THAT HIS COLLEAGUES COMPLAINED ABOUT EXPERIENCING NUMBNESS IN THEIR EARS AFTER SURGERIES WHEN USING THE DEVICE. THE SURGEON REPORTED THAT HE DID NOT EXPERIENCE THE NUMBNESS IN THE EARS HIMSELF. IT WAS REPORTED THAT THE SURGEONS USED THE DEVICES MANY TIMES. ACCORDING TO THE REPORTER, THE DEVICE WORKED FINE; HOWEVER, THEY WERE TOO LOUD. IT WAS UNKNOWN HOW MANY SURGEONS EXPERIENCED THE NUMBNESS IN THE EARS. IT WAS REPORTED THAT THERE WERE NO DELAYS IN THE SURGICAL PROCEDURES. THE REPORTER INDICATED THAT SPARE DEVICES WERE NOT NECESSARY. ACCORDING TO THE REPORTER, THE EVENT OCCURRED DURING MULTIPLE SURGERIES. HOWEVER, THE REPORTER WAS UNABLE TO SPECIFY THE SPECIFIC AMOUNT OF OCCURRENCES, THE TYPE OF SURGERIES, OR THE NUMBER OF PATIENTS INVOLVED. THERE WAS PATIENT INVOLVEMENT REPORTED. IT WAS REPORTED THAT THE PROCEDURES WERE COMPLETED SUCCESSFULLY AND NO MEDICAL INTERVENTIONS WERE REQUIRED. ACCORDING TO THE REPORTER, THERE WAS NO PATIENT HARM, BUT THERE WAS USER HARM DUE TO NUMBNESS OF THE EARS. THE EXACT DATES OF THESE EVENTS WERE 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
    665290 RECON SAGITTAL SAW WITH KEY FOR TRAUMA RECON SYSTEM MOTOR, SURGICAL INSTRUMENT, AC-POWERED GEY DEPUY SYNTHES POWER TOOLS N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention