BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRILL BIT WIRE-PASS M DIAMETER 1.5MM X 7.0MM

    MDR report key: 10876360 · Received November 20, 2020

    Report

    Report Number
    8030965-2020-08873
    Event Type
    Injury
    Date Received
    November 20, 2020
    Date of Event
    October 27, 2020
    Report Date
    October 27, 2020
    Manufacturer
    SYNTHES GMBH
    Product Code
    ERL
    PMA / PMN Number
    K043310
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THIS MEDWATCH, A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED AS APPROPRIATE. THE LOT NUMBER WAS UNKNOWN; THEREFORE, THE DEVICE MANUFACTURE DATE IS UNKNOWN. THE MANUFACTURING LOCATION IS UNKNOWN. 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. UDI: SERIAL NUMBER UNKNOWN; (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY A JOHNSON AND JOHNSON SALES REPRESENTATIVE FROM CANADA THAT THEY WERE CONTACTED BY AN OTOLARYNGOLOGIST INQUIRING ABOUT THE METAL COMPOSITION OF THE DRILL BIT WIRE-PASS DEVICE AND IF IT WAS MRI (MAGNETIC RESONANCE IMAGING) COMPATIBLE. ACCORDING TO THE REPORTER, THE SURGEON STATED THAT THEY HAD A PATIENT IN THEIR CARE WHO HAD A PREVIOUS ORBITAL FRACTURE THAT WAS FIXED BY ANOTHER SURGEON IN A DIFFERENT REGION ¿GTA¿ GREATER TORONTO AREA. THE SURGEON STATED THAT THE PATIENT HAD A FRAGMENT OF A BROKEN DRILL BIT REMAINING IN THEIR BONE FROM THE ORIGINAL SURGERY AND WAS INQUIRING AS TO WHAT THE METAL COMPOSITION OF THE DRILL BIT WAS AND IF THE FRAGMENT WAS COMPATIBLE TO MR (MAGNETIC RESONANCE) AS THE PATIENT MIGHT REQUIRE AN MRI. IT WAS REPORTED THAT THE ORIGINAL PRODUCT MALFUNCTION OCCURRED SEVERAL YEARS AGO WHEN THE DRILL BIT BROKE DURING SURGERY AND A FRAGMENT WAS LEFT IN THE PATIENT¿S BONE. THE REPORTER INDICATED THAT THE PRODUCT INFORMATION WAS NOT AVAILABLE, AND THE SURGEON DID NOT PROVIDE ANY DETAILS OF THE ORIGINAL SURGERY AS IT WAS PERFORMED BY A DIFFERENT SURGEON, IN A DIFFERENT REGION. HOWEVER, THE SURGEON STATED THAT THE PERSON WHO PERFORMED THE ORIGINAL SURGERY MUST HAVE THE SURGICAL NOTES OR IMPLANT STICKERS FROM THE ORIGINAL PROCEDURE. THE REPORTER STATED THAT THEY PROVIDED THE INFORMATION TO THE SURGEON ABOUT THEIR INQUIRY. IT WAS REPORTED THAT THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE. IT WAS NOT REPORTED IF A SPARE DEVICE WERE AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT REPORTED. IT WAS NOT REPORTED IF THERE WAS ANY MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION REQUIRED AS A RESULT OF THE ORIGINAL EVENT. THE EXACT DATE OF THE ORIGINAL 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
    1342059 DRILL BIT WIRE-PASS M DIAMETER 1.5MM X 7.0MM DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention