BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VELYS ARRAY CLAMP

    MDR report key: 12896365 · Received November 30, 2021

    Report

    Report Number
    1818910-2021-26528
    Event Type
    Malfunction
    Date Received
    November 30, 2021
    Date of Event
    January 1, 2021
    Report Date
    November 30, 2021
    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. REPORTER¿S COMPLETE MAILING ADDRESS IS NOT AVAILABLE. REPORTER¿S PHONE NUMBER IS NOT AVAILABLE. 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 CADAVER LAB TRAINING, THE ARRAY CLAMP DEVICE BROKE DURING USE. IT WAS REPORTED THAT IT WAS STILL ABLE TO HOLD THE ARRAY, HOWEVER, IT WAS NOT STABLE AND MOVED DURING THE DEMONSTRATION. IT WAS REPORTED THAT THE DEMONSTRATION COULD NOT BE CONTINUED SINCE THE ARRAY MOVING MADE IT DIFFICULT TO CONTINUE WITH THE CASE. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THIS EVENT WAS UNKNOWN BUT WAS NOTED TO HAVE OCCURRED IN 2021. 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
    1792518 VELYS ARRAY CLAMP ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO DEPUY IRELAND UC 4515-70-107 10603295519379

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown