BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSCILLATING SAW ATTACHMENT

    MDR report key: 7804475 · Received August 22, 2018

    Report

    Report Number
    0008031000-2018-00023
    Event Type
    Injury
    Date Received
    August 22, 2018
    Date of Event
    July 15, 2018
    Report Date
    July 31, 2019
    Manufacturer
    ZIMMER SURGICAL SA
    Product Code
    HAB
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SEVERAL ATTEMPS WERE DONE TO RETRIEVE THE UNIVERSAL OSCILLATING SAW ATTACHMENT, SERIAL NUMBER (B)(4) WITHOUT ANY SUCCESS. THEREFORE, THE DEVICE COULD NOT BE INSPECTED IN AN EFFORT TO CONFIRM THE DEFECT. DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND NO ISSUE WAS DISCOVERED DURING THE MANUFACTURING PROCESS THAT COULD EXPLAIN THE DEFECT REPORTED. A FOLLOW-UP MEDWATCH WILL BE SUBMITED IF THE PRODUCT IS RETURNED OR IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 0

    UNIVERSAL OSCILLATING SAW, SERIAL NUMBER (B)(4), WAS RETURNED FOR COMPLAINT INVESTIGATION. VISUAL AND FUNCTIONAL TESTS WERE PERFORMED. UPON RECEIPT, IT WAS CONFIRMED THAT DEVICE WAS NOT FUNCTIONAL DUE TO ISSUE WITH RATCHET SYSTEM. THE DEVICE HAS NOT BEEN REPAIRED YET.

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT (B)(4). OSCILLATING SAW ATTACHMENT, PART NUMBER 89-8509-450-60, SERIAL NUMBER (B)(4), WAS RETURNED FOR COMPLAINT INVESTIGATION. VISUAL AND FUNCTIONAL TESTS WERE PERFORMED. UPON RECEIPT, IT WAS CONFIRMED THAT THE DEVICE HAD A MALFUNCTIONING RATCHET SYSTEM. AS REPAIR, THE RATCHET SYSTEM WAS REPLACED. AFTER REPAIR, THE DEVICE PASSED FINAL TESTS AND IT WAS RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE OSCILLATING SAW ATTACHMENT PART NUMBER 89-8509-450-60 SERIAL NUMBER (B)(4) FAILED TO HOLD THE SAW BLADE IN PLACE DURING OSTEOTOMY. THE SURGERY DELAY WAS 45 MINUTES DUE TO THE TIME NEEDED TO STERILIZE ANOTHER PRODUCT TO COMPLETE THE SURGERY. THERE WAS NO ADDITIONAL HARM OR INJURY TO PATIENT / OPERATOR REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE OSCILLATING SAW ATTACHMENT PART NUMBER 89-8509-450-60 SERIAL NUMBER (B)(4) FAILED TO HOLD THE SAW BLADE IN PLACE DURING OSTEOTOMY. THE SURGERY DELAY WAS 45 MINUTES DUE TO THE TIME NEEDED TO STERILIZE ANOTHER PRODUCT TO COMPLETE THE SURGERY. THERE WAS NO ADDITIONAL HARM OR INJURY TO PATIENT / OPERATOR REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE OSCILLATING SAW ATTACHMENT PART NUMBER 89-8509-450-60 SERIAL NUMBER (B)(4) FAILED TO HOLD THE SAW BLADE IN PLACE DURING OSTEOTEMY. THE SURGERY DELAY WAS 45 MINUTES DUE TO THE TIME NEEDED TO STERILIZE ANOTHER PRODUCT TO COMPLETE THE SURGERY. THERE WAS NO ADDITIONAL HARM OR INJURY TO PATIENT / OPERATOR REPORTED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER AT THE DATE OF THIS REPORT. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETED OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE OSCILLATING SAW ATTACHMENT PART NUMBER 89-8509-450-60, SERIAL NUMBER (B)(4) FAILED TO HOLD THE SAW BLADE IN PLACE DURING OSTEOTOMY. THE SURGERY DELAY WAS 45 MINUTES DUE TO THE TIME NEEDED TO STERILIZE ANOTHER PRODUCT TO COMPLETE THE SURGERY. THERE WAS NO ADDITIONAL HARM OR INJURY TO PATIENT / OPERATOR REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    647934 OSCILLATING SAW ATTACHMENT OSCILLATING SAW ATTACHMENT HAB ZIMMER SURGICAL SA NA 5006777

    Patients

    Seq Age Sex Outcome Treatment
    1 Other