BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VELYS ARRAY CLAMP

    MDR report key: 13357699 · Received January 26, 2022

    Report

    Report Number
    1818910-2022-01637
    Event Type
    Malfunction
    Date Received
    January 26, 2022
    Date of Event
    December 28, 2021
    Report Date
    January 26, 2022
    Manufacturer
    DEPUY IRELAND UC
    Product Code
    OLO
    UDI-DI
    10603295519379
    PMA / PMN Number
    K202769
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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, BASE STATION DEVICE AND FIXATION PIN DEVICE AND ARRAY DEVICE, (B)(6) 2021. THE DEVICE SERIAL OR LOT NUMBER WAS UNKNOWN; THEREFORE, UDI: (B)(4).

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE ARRAY CLAMP DEVICE WHILE BEING USED WITH AN ARRAY DEVICE AND A FIXATION PIN, MOVED WHEN THE SURGEON'S FOREARM BUMPED THE ARRAY. IT WAS REPORTED THAT THE SYSTEM WAS UNABLE TO RECOGNIZE THE ARRAY DEVICE AT THIS POINT AND SO THE DECISION WAS MADE TO SWITCH TO MANUAL. 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
    1115688 VELYS ARRAY CLAMP ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO DEPUY IRELAND UC 4515-70-107 10603295519379

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown