BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIPTIGHT ACROMIOCLAVICULAR JOINT 1 ZIPLOOP

    MDR report key: 6875440 · Received September 19, 2017

    Report

    Report Number
    0001825034-2017-07160
    Event Type
    Injury
    Date Received
    September 19, 2017
    Date of Event
    August 22, 2017
    Report Date
    November 17, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBI
    PMA / PMN Number
    PK130033
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE PHOTOGRAPHS WERE EVALUATED, AND THE REPORTED EVENT WAS CONFIRMED. PRODUCT WAS RETURNED AND PHOTOS WERE TAKEN. IN REVIEWING THE PHOTOS, THE ZIPLOOP SUTURES WERE CUT UPON REMOVAL FROM THE PATIENT DURING THE SURGERY AND THE BUTTON HAS BEEN DISCONNECTED. THE PRODUCT WAS RETURNED, BUT THE TOGGLELOC BUTTON WAS LOST IN THE DECONTAMINATION PROCESS SO NO DIMENSIONAL ANALYSIS CAN BE PERFORMED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION(S) IS/ARE REQUIRED. ROOT CAUSE WAS UNABLE TO 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.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: PART # 904834 / LOT # 696450. FOREIGN: (B)(6). THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ACROMIOCLAVICULAR JOINT REPAIR THE PRODUCT PULLED OUT OF THE PATIENTS BURR HOLE IN THE CORACOID PROCESS. AN ALTERNATE PRODUCT WAS USED, HOWEVER, BOTH PROVED UNSUCCESSFUL. SUBSEQUENTLY, THE SURGEON DRILLED A NEW BURR HOLE IN THE PATIENTS CORACOID PROCESS AND USED THE SECOND PRODUCT TO COMPLETE THE SURGERY SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655757 ZIPTIGHT ACROMIOCLAVICULAR JOINT 1 ZIPLOOP FASTENER, FIXATION MBI ZIMMER BIOMET, INC. N/A 546100

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ZIPTIGHT ACROMIOCLAVICULAR JOINT 1 ZIPLOOP REF.H10