BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VELYS SAW INTERFACE RIGHT

    MDR report key: 13282085 · Received January 18, 2022

    Report

    Report Number
    1818910-2022-00878
    Event Type
    Malfunction
    Date Received
    January 18, 2022
    Date of Event
    January 6, 2022
    Report Date
    January 18, 2022
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    HWM
    UDI-DI
    10603295519478
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. H10 ADDITIONAL NARRATIVE: INVESTIGATION SUMMARY: EXAMINATION OF THE RETURNED DEVICE DID NOT CONFIRM THE COMPLAINT OF "LOCKING MECHANISM DOES NOT FUNCTION". HOWEVER, LOOSE CONDITION IS CONFIRMED. THE COMPLAINT SAMPLE WAS FORWARDED TO PRODUCT DEVELOPMENT FOR FURTHER EVALUATION (SEE REPORT ATTACHED FOR FURTHER DETAILS). VISUAL INSPECTION UNDER MAGNIFICATION AND TEST FIT WITH MATING PARTS WERE PERFORMED. SASI WAS CHECKED FOR FIT WITH REPRESENTATIVE SAW HANDPIECE (RBY-V-SH-262). SLIGHT TOGGLE NOTED IN INTERFACE BUT NOT SUBSTANTIAL. BOTH SPRINGS ARE DEFORMED DUE TO OVER COMPRESSION. THIS HAS NO IMPACT ON ACCURACY AS ARRAYS ARE MOUNTED DIRECTLY TO THE SAW HANDPIECE. A REVIEW OF THE DEVICE MANUFACTURING RECORDS INDICATE THAT THERE WERE NO ANOMALIES WITH REGARD TO MANUFACTURING OR INSPECTION CONTAINED IN THE DEVICE HISTORY RECORDS THAT WOULD CONTRIBUTE TO THE REPORTED EVENT. A SEARCH OF THE DEPUY NONCONFORMANCE (NC) QUALITY SYSTEM FOUND NO NC¿S ASSOCIATED WITH THIS PRODUCT/LOT COMBINATION. SEE ATTACHED PRODUCT DEVELOPMENT REPORT FOR DETAILS. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    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 SYNTHESE, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHESE, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. THE ACTUAL DEVICE HAS BEEN RETURNED AND IS CURRENTLY PENDING EVALUATION. ONCE THE DEVICE HAS BEEN EVALUATED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY. D11, CONCOMITANT MEDICAL DEVICES AND THERAPY DATES, ARRAY CLAMP DEVICE AND ROBOTIC-ASSISTED SAW SOLUTION SAW INTERFACE RIGHT DEVICE, (B)(6) 2022. CORRECTED DATA: D2B: THE DEVICE PRO-CODE WAS REPORTED AS HWM IN THE INITIAL REPORT AND HAS BEEN UPDATED ACCORDINGLY. B5: THE EVENT DESCRIPTION HAS BEEN UPDATED TO INCLUDE ADDITIONAL EVENT INFORMATION AND CONCOMITANT DEVICES.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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 · 0

    THIS IS REPORT 2 OF 3 FOR THE SAME EVENT. IT WAS REPORTED THAT WHILE SETTING UP FOR SURGERY, IT WAS OBSERVED THAT THE ARRAY CLAMPS (X2) WERE NOT HOLDING THE ARRAYS SECURELY WHEN THE ARRAY IS PHYSICALLY MOVED AND THE BUTTON IS NOT PUSHED. IT WAS ALSO REPORTED THAT THE DURING THE SAME PRE-SURGERY SET UP IT WAS DISCOVERED THAT THE ROBOTIC-ASSISTED SAW SOLUTION SAW INTERFACE RIGHT DEVICE WAS NOT CLAMPING SECURELY. IT WAS REPORTED THAT THE ISSUES WERE DISCOVERED PRIOR TO THE BEGINNING OF THE SURGERY AND THEREFORE THE PROCEDURE WAS CANCELLED AND RE-SCHEDULED FOR ANOTHER DAY. 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.

    Description of Event or Problem · 0

    THE ARRAY CLAMPS ARE NOT HOLDING THE ARRAYS SECURELY IF THE ARRAY IS PHYSICALLY MOVED AND BUTTON IS NOT BEING PUSHED. RIGHT SASI IS NOT CLAMPING SECURELY. BOTH ISSUES WERE DISCOVERED BEFORE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152151 VELYS SAW INTERFACE RIGHT ORTHOPEDIC STEREOTAXIC INSTRUMENT HWM DEPUY IRELAND - 9616671 4515-70-106 J44179 10603295519478

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown