BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZNN, CMN LAG SCREW REAMER, SHORT

    MDR report key: 12589553 · Received October 7, 2021

    Report

    Report Number
    0009613350-2021-00518
    Event Type
    Malfunction
    Date Received
    October 7, 2021
    Date of Event
    September 23, 2021
    Report Date
    December 10, 2021
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    HSB
    UDI-DI
    00889024276260
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EVENT: IT WAS REPORTED THAT: "LAG SCREW REAMER TIP BROKE INSIDE PATIENT BUT WAS SAFELY RETRIEVED AND CONFIRMED WITH XRAY. - NO RELEVANT MEDICAL DATA HAS BEEN RECEIVED. - VISUAL EXAMINATION: THE LAG SCREW REAMER WAS RETURNED FOR INVESTIGATION. IT CAN BE SEEN THAT THE TIP OF THE INSTRUMENT WAS BROKEN. THE BROKEN PIECE HAS NOT BEEN RETURNED FOR EVALUATION. NO OTHER DAMAGES OR DEFORMATIONS CAN BE DETECTED. - THE PRODUCT IS INTENDED FOR TREATMENT. - THE INVESTIGATION RESULTS DID NOT IDENTIFY A NON-CONFORMANCE OR A COMPLAINT OUT OF BOX (COOB). - BASED ON THE LACK OF INFORMATION REGARDING THE EVENT AND THE RESULTS OF THE INVESTIGATION, WE WERE NOT ABLE TO IDENTIFY A SPECIFIC ROOT CAUSE FOR THIS ISSUE. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER SWITZERLAND MANUFACTURING GMBH CONSIDERS THIS CASE AS CLOSED. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 0

    NO CHANGE TO PREVIOUSLY REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    MEDICAL PRODUCT: Z NAIL 10.5 X 110 LAG SCREW; CATALOG#: 47-2485-110-10; LOT#: 3061196. Z NAIL 5.0X35 CORT SCREW FA; CATALOG#: 47-2484-035-50; LOT#: 65133376. ZNN, CMN THREADED PIN, 3.2 MM; CATALOG#: 00-2490-450-32; LOT#: UNKNOWN. ZNN, CMN DRILL, CALIBRATED, 4.3 MM; CATALOG#: 00-2490-066-43; LOT#: UNKNOWN. CMN FEMORAL NAIL, CCD 130, LEFT, 11.5 MM, 21.5 CM; CATALOG#: 47-2493-213-11; LOT#: UNKNOWN. THE MANUFACTURER DID NOT RECEIVE X-RAYS FOR REVIEW. OTHER SOURCE DOCUMENTS WERE RECEIVED AND WILL BE REVIEWED AS PART OF ONGOING INVESTIGATION. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. THE LOT NUMBER OF THE DEVICE WAS RECEIVED. THE DEVICE HISTORY RECORDS WILL BE REVIEWED DURING INVESTIGATION. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. AS SOON AS SUPPLEMENTAL INFORMATION BECOMES AVAILABLE AN UPDATED REPORT WILL BE SUBMITTED. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY THE TIP OF THE LAG SCREW REAMER FRACTURED INSIDE THE PATIENT. IT WAS SAFELY RETRIEVED AND CONFIRMED WITH X-RAY. NOTE: THE IMPLANTATION AND EXPLANTATION DATES ARE LEFT EMPTY AS THE DEVICE INVOLVED IN THIS COMPLAINT IS AN INSTRUMENT. HENCE, NO EXPIRATION DATE IS CAPTURED, FOR THE SAME REASON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1493036 ZNN, CMN LAG SCREW REAMER, SHORT TRAUMA INSTRUMENT HSB ZIMMER SWITZERLAND MANUFACTURING GMBH N/A 16277660 00889024276260

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Female Hospitalization SEE H10 NARRATIVE