BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHUCK WITH KEY/DRILL SPEED FOR TRS

    MDR report key: 15018045 · Received July 14, 2022

    Report

    Report Number
    8030965-2022-04853
    Event Type
    Malfunction
    Date Received
    July 14, 2022
    Date of Event
    July 7, 2022
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    UDI-DI
    07611819977860
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. 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. UDI ¿ (B)(4).

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. 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. H10 ADDITIONAL NARRATIVE: THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. DURING REPAIR, AN EVALUATION WAS PERFORMED AND IT WAS DETERMINED THAT THE CHUCK WITH KEY DEVICE WOULD NOT TURN/ROTATE, THE ATTACHMENT SEIZED, THE BEARING SEIZED IN THE HOUSING, UNABLE TO REMOVE DURING DISASSEMBLY. IT WAS NOTED THAT THE MECHANICS SEIZED, WAS FROZEN/WILL NOT MOVE, DIFFICULT TO DISASSEMBLE/ASSEMBLE. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR GENERAL CONDITION, CHECK THE HANDPIECE COUPLING, CHECK PINS LENGTH OF HANDPIECE COUPLING, CHECK FOR MECHANICAL FREE MOVEMENT, CHECK GENERAL FUNCTION IN RUNNING MODE. THEREFORE, THE REPORTED CONDITION THAT THE DEVICE WAS NOT WORKING WAS CONFIRMED. THE ASSIGNABLE ROOT CAUSE OF THIS CONDITION WAS DETERMINED TO BE TRACED TO COMPONENT FAILURE DUE TO WEAR. CORRECTION D4: PLEASE NOTE THAT THE SERIAL NUMBER WAS INADVERTENTLY ENTERED INTO THE LOT NUMBER SECTION OF THE INITIAL REPORT. THE SERIAL NUMBER HAS BEEN UPDATED ACCORDINGLY IN SECTION D4.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. 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. H10 ADDITIONAL NARRATIVE: ADDITIONAL INFORMATION B5: UPON FURTHER INVESTIGATION WITH THE AFFILIATE ADDITIONAL INFORMATION WAS RECEIVED. THE REPORTER STATED THAT THE DRILL BIT OR GUIDE PIN CAN BE MOUNTED ON THE CHUCK, BUT WHEN COMBINED WITH THE HANDPIECE AND OPERATED, IT DOES NOT OPERATE WITHOUT ROTATIONAL MOVEMENT. THE ACTUAL DEVICE HAS BEEN RETURNED AND IS CURRENTLY PENDING EVALUATION. ONCE THE EVALUATION OF THE DEVICE HAS BEEN COMPLETED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY.

    Description of Event or Problem · 0

    IT WAS REPORTED FROM SOUTH KOREA THAT DURING PRE-SURGERY TESTING IT WAS OBSERVED THAT THE CHUCK WITH KEY DEVICE DID NOT WORK EVEN WHEN A KEY WAS USED. IT WAS REPORTED THAT THE DEVICE DID NOT ROTATE EVEN IF IT WAS ATTACHED TO THE BODY. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. 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 WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2557240 CHUCK WITH KEY/DRILL SPEED FOR TRS INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT HWE SYNTHES GMBH 106537 07611819977860

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown