BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XBACK GB ACE GRATER 48MM

    MDR report key: 18480838 · Received January 9, 2024

    Report

    Report Number
    1818910-2024-00702
    Event Type
    Malfunction
    Date Received
    January 9, 2024
    Date of Event
    January 1, 2024
    Report Date
    January 9, 2024
    Manufacturer
    JOINT RECON : VIANT MEDICAL (FORMERLY GREATBATCH)
    Product Code
    HTO
    UDI-DI
    00840096400557
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). 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.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY : AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED AS THE REQUIRED PRODUCT IDENTIFICATION NUMBER WAS NOT PROVIDED TO COMPLETE THE EVALUATION. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF THE POST-MARKET SURVEILLANCE. HOWEVER, IF THE PRODUCT OR PRODUCT ID NUMBERS ARE RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS PRODUCT WAS REPORTED IN ERROR. DEPUY IS NOT THE MANUFACTURER OR SUPPLIER OF THIS PRODUCT. NO PATIENT DEATH, SERIOUS INJURY OR EVIDENCE OF REPORTABLE PRODUCT MALFUNCTION OCCURRED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 0

    ACETABULAR GRATERS HAVE BECOME DULL. PATIENT STATUS/ OUTCOME / CONSEQUENCES --> NO PATIENT INVOLVEMENT, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: --> UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY --> UNKNOWN, IP-01937713 DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE, IP-01937714 DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE, IP-01937715 DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE, IP-01937716 DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE, IP-01937717 DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE, IP-01937718 DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE, IP-01937719 DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE, IP-01937720 DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE, IP-01937721 DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE, IP-01937722 DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE, IP-01937723 DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE, IP-01937724 DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE, IP-01937725 DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE, IP-01937726 DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE, IP-01937727 DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST.--> TRUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633085 XBACK GB ACE GRATER 48MM HIP INSTRUMENTS : REAMERS HTO JOINT RECON : VIANT MEDICAL (FORMERLY GREATBATCH) 00840096400557

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown