BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFFIXUS HIP FRACTURE NAIL 125 DEG 9MM X 180MM

    MDR report key: 6739504 · Received July 25, 2017

    Report

    Report Number
    0001825034-2017-05191
    Event Type
    Injury
    Date Received
    July 25, 2017
    Date of Event
    June 28, 2017
    Report Date
    January 9, 2018
    Manufacturer
    BIOMET TRAUMA
    Product Code
    HSB
    PMA / PMN Number
    PK100238
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL PRODUCT - INSERTION JIG 125 DEGREE, CAT#: 211201200 LOT#: E73DF4. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-05191 AND 0001825034-2017-05197.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CORRECTED: MODEL #/LOT #: LOT NUMBER: 153150 OR 153160, EXPIRATION DATE: APR 25, 2027 OR APR 24, 2027. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. THE RETURNED DEVICE IS ONE 125-DEGREE AFFIXUS HIP FRACTURE NAIL, PN 814309180 LN 5550103, ALONG WITH THE ASSOCIATED 125-DEGREE TARGETING JIG AND CONNECTING BOLT. VISUALLY, THE NAIL AND JIG ARE UNREMARKABLE, WITH A SMALL AMOUNT OF COSMETIC WEAR LIKELY DUE TO IMPLANTATION, EXPLANTATION, AND STERILIZATION. THE CONNECTING BOLT SHOWS WEAR - BUT NOT TO THE POINT OF BEING STRIPPED. FUNCTIONAL TESTING REVEALS THE BOLT TO BE FUSED TO THE NAIL, CONFIRMING THIS COMPLAINT. THE LOT NUMBER ETCHED ON THE DEVICE, 5550103, CORRESPONDS TO THE COMPONENT PART 814309180-00. A REVIEW OF MANUFACTURING RECORDS SHOWS THAT THIS WAS ISSUED TO TWO FINISHED GOODS LOTS OF ITEM 814309180, LOT 153150 AND LOT 153160. 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

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. PRODUCT HAS BEEN RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A HIP FRACTURE NAILING PROCEDURE, THE CONNECTING JIG BOLT WAS LOCKED IN THE NAIL AND COULD NOT BE DISLODGED OR REMOVED. AS A RESULT, THE ENTIRE SYSTEM HAD TO BE REMOVED FROM THE PATIENT. A COMPETITOR PRODUCT WAS USED TO COMPLETE THE PROCEDURE WITH MINIMAL DELAY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522436 AFFIXUS HIP FRACTURE NAIL 125 DEG 9MM X 180MM ROD, FIXATION HSB BIOMET TRAUMA N/A SEE H10 NARRATIVE

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention