BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUGGERSTITCH CURVED IMPLANT

    MDR report key: 17166706 · Received June 20, 2023

    Report

    Report Number
    0001825034-2023-01384
    Event Type
    Injury
    Date Received
    June 20, 2023
    Date of Event
    May 9, 2023
    Report Date
    November 22, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBI
    UDI-DI
    00880304690073
    PMA / PMN Number
    K191459
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: MEDICAL PRODUCTS: ITEM#: 110024773, JUGGERSTITCH CURVED IMPLANT; LOT#: 65868207 UDI: (B)(4). ITEM#: 110024773, JUGGERSTITCH CURVED IMPLANT; LOT#: 65868207 UDI: (B)(4). ITEM#: 110024773, JUGGERSTITCH CURVED IMPLANT; LOT#: 65869077 UDI: (B)(4). ITEM#: 110024773, JUGGERSTITCH CURVED IMPLANT; LOT#: 65869077 UDI: (B)(4). IT WAS REPORTED THAT MULTIPLE PRODUCTS WERE USED IN THE EVENT AND THAT IT WAS UNDETERMINED WHICH ITEM WAS RETAINED BY THE PATIENT. H3: CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT WAS DISCARDED BY THE HOSPITAL. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. D4: ITEM#: 110024773, JUGGERSTITCH CURVED IMPLANT; LOT#: 65868207 EXPIRATION DATE: FEB 10, 2028 UDI: (B)(6). ITEM#: 110024773, JUGGERSTITCH CURVED IMPLANT; LOT#: 65869077 EXPIRATION DATE: FEB 21 2028 UDI: (B)(6). H4: ITEM#: 110024773, JUGGERSTITCH CURVED IMPLANT; LOT#: 65868207 MANUFACTURE DATE: FEB 10, 2023. ITEM#: 110024773, JUGGERSTITCH CURVED IMPLANT; LOT#: 65869077 MANUFACTURE DATE: FEB 21, 2023. VISUAL EXAMINATION OF THE PROVIDED PICTURES IDENTIFIED THE FRACTURED END OF A JUGGERSTITCH NEEDLE. NO PRODUCT IDENTIFICATION IS PICTURED. FRACTURE ANALYSIS HAS BEEN PREVIOUSLY ANALYZED WHERE BENDING OVERLOAD WAS IDENTIFIED AS THE MODE OF FAILURE FOR THIS PART NUMBER. LOT 65868207: REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. LOT 65896077: REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. MEDICAL RECORDS/RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: THE RETAINED JUGGERSTITCH NEEDLE IS CONFIRMED ON THE FIRST IMAGE IT IS SEEN POSTERIORLY. NO SIGNIFICANT ABNORMALITIES ARE SEEN IN THE KNEE JOINT WHICH WERE CONTRIBUTED FROM THE RETAINED JUGGERSTITCH NEEDLE. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT KNEE SURGERY AND DURING THE SURGERY THE NEEDLE OF THE INSTRUMENT FRACTURED AND WAS RETAINED BY THE PATIENT. SUBSEQUENTLY, THE FOREIGN BODY WAS NOT FOUND UNTIL A FOLLOW UP VISIT WITH THE SURGEON. AT THAT TIME THE SURGEON WAS ABLE TO REMOVE THE FOREIGN BODY IN THEIR OFFICE AS THE FOREIGN BODY HAD BECOME SUPERFICIAL AND EXPOSED THROUGH THE PATIENT'S SKIN.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545105 JUGGERSTITCH CURVED IMPLANT FASTNER, FIXATION, NONDEGRADABLE, SOFT TISSUE/SPORTS MEDICINE MBI ZIMMER BIOMET, INC. 110024773 65868207 00880304690073

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Female Hospitalization