BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAMER Ø6/10 CANN L435 NO. 511.760

    MDR report key: 3677670 · Received March 13, 2014

    Report

    Report Number
    1719045-2014-10041
    Event Type
    Malfunction
    Date Received
    March 13, 2014
    Date of Event
    February 17, 2014
    Report Date
    February 17, 2014
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTO
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(4). REVIEW OF THE DEVICE HISTORY RECORDS FOR PART NUMBER 357.403, LOT U132365, SHOWED NO NONCONFORMANCES GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. 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

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING PREPARATION OF THE FEMORAL NECK, THE DRILL BIT 11.0 MM, CONICAL, CANNULATED, LENGTH 280 MM HAS BROKEN. TO REMOVE THE DRILL BIT FRAGMENT, IT WAS NECESSARY TO REMOVE THE (TFN) TROCHANTERIC FIXATION NAIL, WHICH ALLOWED THE VERIFICATION THAT THE NAIL LOCKING MECHANISM, WAS LOOSENED AND AVOIDING THE SCREW CONNECTION BETWEEN THE AIMING ARM AND THE NAIL, LOCK PROPERLY. IT WAS REPORTED THAT THERE IS NO INFORMATION ABOUT NON-STERILE (TFN) TROCHANTERIC FIXATION NAIL; HOWEVER, EXTRA CARE SHOULD BE TAKEN, BECAUSE THERE IS NO CONTROL IN THE POSITION OF THE LOCKING MECHANISM. THE SALES REPRESENTATIVE WAS PRESENT DURING THE PROCEDURE. THIS REPORT IS FOR 1 OF 1 COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149990 REAMER Ø6/10 CANN L435 NO. 511.760 REAMER HTO SYNTHES MONUMENT U132365

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR