BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN JUGGERKNOT

    MDR report key: 18606843 · Received January 30, 2024

    Report

    Report Number
    0001825034-2024-00178
    Event Type
    Malfunction
    Date Received
    January 30, 2024
    Date of Event
    January 3, 2024
    Report Date
    April 11, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBI
    PMA / PMN Number
    NI
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. D4/H4: IT WAS REPORTED THAT THE EXACT LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. HOWEVER, THERE ARE FOUR (4) POTENTIAL LOT NUMBERS OF THE DEVICE INVOLVED. THESE ARE LISTED BELOW WITH THEIR ASSOCIATED DATES OF MANUFACTURE, EXPIRATION DATES, AND UDIS: 0002534639: 7/3/2023, 7/3/2028, (B)(4). 0002542093: 8/16/2023, 8/16/2028, (B)(4). 0002530045: 6/16/2023, 6/16/2028, (B)(4). 0002549690: 9/1/2023, 9/1/2028, (B)(4). THE PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. IF ANY FURTHER INFORMATION WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED ONE TINE OF THE INSERTER IS FRACTURED AND WAS NOT RETURNED. FRACTURE ANALYSIS HAS BEEN PREVIOUSLY ANALYZED IN WHICH BENDING OVERLOAD WAS IDENTIFIED AS THE MODE OF FAILURE. REVIEW OF THE DEVICE HISTORY RECORD(S) FOR ALL POTENTIAL LOTS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE REPORTED EVENT HAS BEEN CONFIRMED THROUGH PRODUCT RETURN. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4). D10: ASSOCIATED PRODUCT INFORMATION, PART NUMBER (LOT NUMBER): 912031 (0002534639); 912031 (0002542093); 912031 (0002530045); 912031 (0002549690). THE CUSTOMER HAS NOT INDICATED WHETHER THE PRODUCT WILL BE ZIMMER BIOMET FOR INVESTIGATION, AND THE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. IF ANY FURTHER INFORMATION IS FOUND THAT WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN INITIAL LABRAL REPAIR SURGERY, ONE-HALF OF THE TINE FROM THE INSERTER FRACTURED. THE CORRECT SURGICAL TECHNIQUE WAS USED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH AN ALTERNATE DEVICE. NO COMPLICATIONS, INJURIES, OR SURGICAL INTERVENTIONS WERE REPORTED, AND NO FOREIGN BODIES WERE RETAINED DUE TO THIS MALFUNCTION. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN INITIAL LABRAL REPAIR SURGERY, ONE-HALF OF THE TINE FROM THE INSERTER FRACTURED. THE CORRECT SURGICAL TECHNIQUE WAS USED. NO COMPLICATIONS, INJURIES, OR SURGICAL INTERVENTIONS WERE REPORTED, AND NO FOREIGN BODIES WERE RETAINED DUE TO THIS MALFUNCTION. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    988521 UNKNOWN JUGGERKNOT FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI ZIMMER BIOMET, INC. NI H10

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Male H10