BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VELYS ARRAY CLAMP

    MDR report key: 13862718 · Received March 23, 2022

    Report

    Report Number
    1818910-2022-05106
    Event Type
    Malfunction
    Date Received
    March 23, 2022
    Date of Event
    March 9, 2022
    Report Date
    March 21, 2022
    Manufacturer
    DEPUY IRELAND UC
    Product Code
    OLO
    UDI-DI
    10603295519379
    PMA / PMN Number
    K202769
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED. DEVICE MANUFACTURE DATE IS UNKNOWN. THE DEVICE SERIAL OR LOT NUMBER IS UNKNOWN. CONCOMITANT MEDICAL DEVICES AND THERAPY DATES, ARRAY CLAMP DEVICE, (B)(6) 2022. THE DEVICE SERIAL OR LOT NUMBER WAS UNKNOWN; THEREFORE, 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. 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. INVESTIGATION SUMMARY: AFTER MULTIPLE REQUESTS, THE CUSTOMER HAS NOT RETURNED THE DEVICE FOR EVALUATION / REPAIR TO ANY JNJ SITE AND THEREFORE THE COMPLAINT CANNOT BE CONFIRMED, AND NO CONCLUSION CAN BE DRAWN AT THIS TIME. THE COMPLAINT WILL BE REOPENED UPON RECEIVING THE DEVICE FOR REPAIR FROM THE CUSTOMER. DEVICE HISTORY LOT : THE PRODUCT INVESTIGATION FOUND NO EVIDENCE SUSPECTING AN ERROR IN THE MANUFACTURING OR MATERIAL THAT WOULD BE A CONTRIBUTING FACTOR IN THE REPORTED ALLEGATION(S). A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED.

    Description of Event or Problem · 0

    THIS IS REPORT 1 OF 2 FOR THE SAME EVENT. IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE ARRAY CLAMP DEVICES (X2) WERE LOOSE AND THE CLINICIAN BELIEVES THERE WAS A RISK OF KNOCKING THEM LOOSE DURING THE PROCEDURE. IT WAS REPORTED THAT THERE WERE NO DELAYS IN THE PROCEDURE. IT WAS REPORTED THAT THERE WAS NO PATIENT HARM AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO 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
    801766 VELYS ARRAY CLAMP ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO DEPUY IRELAND UC 4515-70-107 10603295519379

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown