BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VELYS SAW INTERFACE RIGHT

    MDR report key: 13046642 · Received December 20, 2021

    Report

    Report Number
    1818910-2021-28240
    Event Type
    Malfunction
    Date Received
    December 20, 2021
    Date of Event
    November 10, 2021
    Report Date
    December 15, 2021
    Manufacturer
    DEPUY IRELAND UC
    Product Code
    OLO
    UDI-DI
    10603295519478
    PMA / PMN Number
    K202769
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    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.

    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. ADDITIONAL NARRATIVE: AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED. THE DEVICE SERIAL OR LOT NUMBER WAS UNKNOWN; THEREFORE, UDI: (B)(4). DEVICE MANUFACTURE DATE IS UNKNOWN. THE DEVICE SERIAL OR LOT NUMBER IS UNKNOWN.

    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. ADDITIONAL NARRATIVE: AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED. THE DEVICE SERIAL OR LOT NUMBER WAS UNKNOWN; THEREFORE, UDI: (B)(4). DEVICE MANUFACTURE DATE IS UNKNOWN. THE DEVICE SERIAL OR LOT NUMBER IS UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, IT WAS OBSERVED THAT EXCESSIVE MOVEMENT WAS EXPERIENCED WITH THE ROBOTIC-ASSISTED SAW SOLUTION SAW INTERFACE RIGHT DEVICE AND THE ARRAY WAS NOT VISIBLE. THE CASE WAS COMPLETED WITH NO ISSUES. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, IT WAS OBSERVED THAT EXCESSIVE MOVEMENT WAS EXPERIENCED WITH THE ROBOTIC-ASSISTED SAW SOLUTION SAW INTERFACE RIGHT DEVICE AND THE ARRAY WAS NOT VISIBLE. THE CASE WAS COMPLETED WITH NO ISSUES. 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
    1940414 VELYS SAW INTERFACE RIGHT ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO DEPUY IRELAND UC 4515-70-106 10603295519478

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown