BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAMMERLOCK 2 IMPLANT KIT 12X5MM/0 DEGREES/SMALL

    MDR report key: 6913151 · Received October 3, 2017

    Report

    Report Number
    1649263-2017-10018
    Event Type
    Injury
    Date Received
    October 3, 2017
    Report Date
    September 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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT AGE & WEIGHT NOT AVAILABLE FOR REPORTING. UNKNOWN. (B)(4), (17) UNKNOWN, (10) LOT NUMBER UNKNOWN. ORIGINAL IMPLANT DATE IS UNKNOWN. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. 510K UNKNOWN. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORD REVIEW AND THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS NOT RETURNED AND NO LOT NUMBER WAS PROVIDED. BASED ON THE INFORMATION AVAILABLE, THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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 A HAMMER LOCK 2 IMPLANT KIT 12X5MM/0 DEGREES/ SMALL DEVICE WAS REMOVED FROM A PATIENT DURING A REVISION SURGERY OF THE FOURTH METATARSAL OF THE LEFT FOOT. THE DEVICE WAS DISCOVERED BROKEN IN HALF IN PRE-OPERATIVE X-RAYS. THE ORIGINAL IMPLANT DATE WAS APPROXIMATELY 6 MONTHS AGO. THE SURGEON HAD DIFFICULTY REMOVING BOTH PIECES OF THE BROKEN DEVICE, CAUSING A SURGICAL DELAY OF APPROXIMATELY 20 MINUTES. THERE WERE NO FRAGMENTS OF THE DEVICE REMAINING IN THE PATIENT. THERE WAS NO PATIENT HARM AND SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE DEVICE WILL NOT BE RETURNED AS IT IS EXPECTED TO BE DISPOSED OF AT THE HOSPITAL. THE SALES CONSULTANT HAS X-RAYS OF THE DEVICE BOTH INSIDE THE PATIENT AND AFTER IT WAS REMOVED. NO REPLACEMENT DEVICE IS REQUIRED. THIS COMPLAINT HAS 1 DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    689272 HAMMERLOCK 2 IMPLANT KIT 12X5MM/0 DEGREES/SMALL INTRAMEDULLARY BONE FASTENER HTY BIO MEDICAL ENTERPRISES INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention