BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAMMERLOCK 2 IMPLANT KIT 15X5MM/10 DEGREES/MEDIUM, IMPLANT

    MDR report key: 6711909 · Received July 13, 2017

    Report

    Report Number
    1649263-2017-10014
    Event Type
    Injury
    Date Received
    July 13, 2017
    Date of Event
    June 15, 2017
    Report Date
    June 15, 2017
    Manufacturer
    BIO MEDICAL ENTERPRISES INC
    Product Code
    HTY
    PMA / PMN Number
    K133520
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UDI: (B)(4). IMPLANT AND EXPLANT DATES: DUE TO INTRA-OPERATIVE ISSUES, THE DEVICE WAS NOT IMPLANTED/EXPLANTED. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, AS IT WAS REPORTEDLY DISCARDED BY THE FACILITY. (B)(4). PART HL2MA, BME LOT BHL170033 (PARENT LOTS 1610125292 AND 161125329): MANUFACTURING DATE OR RELEASE TO WAREHOUSE DATE: MARCH 08, 2017. EXPIRATION DATE: FEBRUARY 01, 2022. NO NON-CONFORMANCE REPORTS RELEVANT TO THE COMPLAINT CONDITION WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUBCOMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAD AN INITIAL PROCEDURE ON (B)(6) 2017 ON THE LEFT FOOT SECOND METATARSAL DUE TO THE PATIENT PRESENTING WITH A HAMMER TOE. DURING THIS PROCEDURE, THE SURGEON IMPLANTED THE HAMMERLOCK 2 MEDIUM IMPLANT INTO THE PATIENT'S MEDULLARY METATARSAL BONE. THIS MEDIUM IMPLANT WAS NOT LARGE ENOUGH TO CORRECT THE PATIENT'S BONE DEFORMITY. THE SIZE LARGE HAMMERLOCK 2 IMPLANT WAS ORDERED, BUT THE IMPLANT WAS ON BACK-ORDER. THE LARGER SIZE IMPLANT WAS NOT AVAILABLE IN THIS PROCEDURE FOR THE SURGEON TO USE. AGAIN, DURING THIS PROCEDURE ON (B)(6) 2017 THE MEDIUM SIZED IMPLANT WAS REMOVED AND PATIENT WAS IMPLANTED WITH A HEADLESS COMPRESSION SCREW TO CORRECT THE HAMMER TOE. DUE TO THIS ISSUE, THERE WAS A FIFTEEN (15) MINUTE SURGICAL DELAY TO REMOVE THE IMPLANT AND REVISE THE PATIENT TO A SCREW IMPLANT. ADDITIONAL IMAGES WERE TAKEN. THE SURGERY WAS SUCCESSFULLY COMPLETED AND THE PATIENT WAS REPORTED IN STABLE CONDITION. CONCOMITANT DEVICE: HAMMERLOCK 2 DRILL KIT (PART DK-H2, LOT BDK170010, QUANTITY 1). THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490769 HAMMERLOCK 2 IMPLANT KIT 15X5MM/10 DEGREES/MEDIUM, IMPLANT INTRAMEDULLARY BONE FASTENER HTY BIO MEDICAL ENTERPRISES INC BHL170033

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention