BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLIANCE 4 PEG LEFT AUG REAMER GUIDE

    MDR report key: 20858301 · Received December 5, 2024

    Report

    Report Number
    0001822565-2024-03840
    Event Type
    Malfunction
    Date Received
    December 5, 2024
    Date of Event
    November 11, 2024
    Report Date
    May 6, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    K193180
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D4: MULTIPLE LOT NUMBERS WERE REPORTED FOR THE DEVICE THAT MALFUNCTIONED ITEM SBGL7009, 4 PEG LEFT AUG REAMER GUIDE; LOT#: 66461827. MANU DATE: 1/31/2024. UDI: (B)(4). ITEM SBGL7009, 4 PEG LEFT AUG REAMER GUIDE; LOT#: 65085374. MANU DATE: 4/26/2021. UDI: (B)(4). D10: MEDICAL PRODUCTS: ITEM#: SBGL3701, AUGMENT REAMER DRIVER; LOT#: 64878851. H3: CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT WAS DISCARDED. 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 AND CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4; B5; D2; G2; G3; G6; H1; H2; H3; H6. THE FOLLOWING SECTION WAS CORRECTED: D4; H5. D4: MULTIPLE LOT NUMBERS WERE REPORTED FOR THE DEVICE THAT MALFUNCTIONED ITEM#: SBGL7009, 4 PEG LEFT AUG REAMER GUIDE; LOT#: 66461827. MANUFACTURED DATE: 2024-01-26. EXPIRATION DATE: 2034-01-23. UDI: (B)(4). ITEM#: SBGL7009, 4 PEG LEFT AUG REAMER GUIDE; LOT#: 65085374. MANUFACTURED DATE: 2024-04-20. EXPIRATION DATE: 2031-04-18. UDI: (B)(4). NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. SBGL7009 (LOT 65085374): REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. PART SBGL7009 (LOT 66461827): REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. MEDICAL RECORDS WERE NOT PROVIDED. 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 WHILE THE SURGEON WAS USING THE INSTRUMENT, THE INSTRUMENT FRACTURED. ALL PIECES WERE REMOVED FROM THE PATIENT AND NO THERE WAS NO HARM TO THE PATIENT.

    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
    502062 ALLIANCE 4 PEG LEFT AUG REAMER GUIDE PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED/EXTREMITIES KWS ZIMMER BIOMET, INC. SEE H11 NARRATIVE

    Patients

    Seq Age Sex Outcome Treatment
    1