BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RECON SAGITTAL SAW WITH KEY FOR TRS

    MDR report key: 16564729 · Received March 17, 2023

    Report

    Report Number
    8030965-2023-03288
    Event Type
    Malfunction
    Date Received
    March 17, 2023
    Date of Event
    March 13, 2023
    Manufacturer
    SYNTHES GMBH
    Product Code
    GEY
    UDI-DI
    07611819462588
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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. H10 ADDITIONAL NARRATIVE: AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED. UDI ¿ (01)07611819462588(21)2747

    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. ADDITIONAL NARRATIVE: THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. DURING REPAIR, AN EVALUATION WAS PERFORMED AND IT WAS DETERMINED THAT THE SAW WITH KEY DEVICE HAD A SEIZED BEARING, FAILED THE LEAK TIGHTNESS TEST, HAD COMPONENT DAMAGE, THE LOCKING MECHANISM WAS STIFF/STUCK, A STICKY TRIGGER, WOULD NOT RUN, AND COULD NOT ENGAGE THE ATTACHMENT. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR GENERAL CONDITION, LEAKAGE TEST, CHECK COUPLING SCREW OF SAW BLADE COUPLING, CHECK THE SAW BLADE COUPLING, CHECK THE SAW HEAD¿S LOCKING MECHANISM, CHECK FOR STICKY TRIGGER, CHECK ROUNDNESS OF HOUSING, CHECK FITTING OF THE LID, CHECK GENERAL FUNCTION OF DEVICE, AND CHECK OSCILLATION FREQUENCY WITH FREQUENCY METER. THEREFORE, THE REPORTED CONDITION THAT THE ACTIVATION BUTTON WAS STUCK WAS CONFIRMED. THE ASSIGNABLE ROOT CAUSE OF THIS CONDITION WAS DETERMINED TO BE TRACED TO MAINTENANCE, WHICH IS IMPROPER MAINTENANCE.

    Description of Event or Problem · 0

    IT WAS REPORTED FROM FRANCE THAT DURING PRE-SURGERY TESTING IT WAS OBSERVED THAT WHEN PRESSING THE BUTTON TO ACTIVATE THE SAW WITH KEY DEVICE THE BUTTON BECAME STUCK. 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
    824910 RECON SAGITTAL SAW WITH KEY FOR TRS MOTOR, SURGICAL INSTRUMENT, AC-POWERED GEY SYNTHES GMBH 07611819462588

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown