BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JGRKNT 1.0MM MINI 3-0 NDLS

    MDR report key: 22090016 · Received May 27, 2025

    Report

    Report Number
    0001825034-2025-01499
    Event Type
    Malfunction
    Date Received
    May 27, 2025
    Date of Event
    November 26, 2024
    Report Date
    May 27, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBI
    PMA / PMN Number
    K150768
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT IS RECORDED BY ZIMMER BIOMET UNDER (B)(4). G2, COUNTRY EVENT OCCURRED IN: JAPAN. VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED THREE JUGGERKNOT DEVICES WERE RETURNED AND SHOW SIGNS OF USE. SAMPLE 1: HAS A BENT TIP AND THE CLEAR SLEEVE HAS BEEN PUSHED BACK TO THE HANDLE. THE FOAM CARRIER AND SUTURE REMAIN IN THE HANDLE HOWEVER THE SUTURE AND ANCHOR HAVE COME OFF THE TIP OF THE DEVICE. SAMPLE 2: ALSO HAS A BENT TIP AND THE CLEAR SLEEVE IS NOT PUSHED BACK TO THE HANDLE. THE FOAM CARRIER AND SUTURES REMAIN IN THE HANDLE AND THE SUTURE AND ANCHOR HAVE COME OFF THE TIP OF THE DEVICE. SAMPLE 3: THE FOAM CARRIER WAS NOT RETURNED AND THE SUTURES AND NEEDLES WERE RETURNED IN A WHITE BANDAGE TYPE MATERIAL. THE ANCHOR IS ALSO DISCOLORED/STAINED AND THE CLEAR SLEEVE IS NOT PUSHED BACK TO THE HANDLE. PRODUCT INFORMATION CANNOT BE CONFIRMED FOR EACH DEVICE. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE REPORTED BENT INSERTER EVENT IS CONFIRMED FROM PRODUCT RETURN. THE REPORTED ANCHOR PULLOUT EVENT IS NOT CONFIRMED. D10 NARRATIVE: ITEM: 912082 LOT: 0002600403 ITEM NAME: JGRKNT 1.0MM MINI 3-0 NDLS. ITEM: 912082. LOT: 0002600403. ITEM NAME: JGRKNT 1.0MM MINI 3-0 NDLS. THE DEVICES WERE RETURNED AND EVALUATED WHICH CONFIRMED TWO OUT OF THE THREE DEVICES WERE BENT AT THE TIP. HOWEVER, IT CANNOT BE CONFIRMED WHICH TWO DEVICES HAD A BENT INSERTER AS PRODUCT ID IS NOT ETCHED ON THE RETURNED DEVICES. THEREFORE, THE FOLLOWING SECTIONS COULD NOT BE COMPLETED BECAUSE THE PART/LOT INFORMATION COULD BE: D4 - CATALOG NUMBER - 912082. D4 - LOT NUMBER - 0002600358. D4 - EXPIRATION DATE - FEB 19, 2029. D4 ¿ UDI # - (B)(4). H4 - MANUFACTURE DATE ¿ FEB 19, 2024. OR THE PART/LOT INFORMATION COULD BE: D4 - CATALOG NUMBER - 912082. D4 - LOT NUMBER - 0002600403. D4 - EXPIRATION DATE - FEB 24, 2029. D4 ¿ UDI # - (B)(4). H4 - MANUFACTURE DATE ¿ FEB 24, 2024. OR THE PART/LOT INFORMATION COULD BE: D4 - CATALOG NUMBER - 912082. D4 - LOT NUMBER - 0002600403. D4 - EXPIRATION DATE - FEB 24, 2029. D4 ¿ UDI # - (B)(4). H4 - MANUFACTURE DATE ¿ FEB 24, 2024. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING SURGERY, THAT THE ANCHOR PULLED OUT. THERE WAS NO HARM, INJURY, OR SURGICAL/MEDICAL INTERVENTION TO PATIENT. A DELAY OF APPROXIMATELY 15 MINUTES WAS REPORTED WHILE ANOTHER DEVICE WAS SUBSTITUTED. HOWEVER, UPON EVALUATION OF THE RETURNED PRODUCT, IT WAS DETERMINED THAT THE DEVICE WAS BENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330725 JGRKNT 1.0MM MINI 3-0 NDLS FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI ZIMMER BIOMET, INC. SEE H11

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SEE H11 NARRATIVE