BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAMING ROD MEASURING DEVICE

    MDR report key: 4121949 · Received September 26, 2014

    Report

    Report Number
    1719045-2014-10475
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    September 1, 2014
    Report Date
    September 1, 2014
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. 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.

    Additional Manufacturer Narrative · 1

    A PRODUCT DEVELOPMENT EVALUATION WAS COMPLETED: THE (360.255,LOT 38231389) REAMING ROD MEASURING DEVICE WAS RECEIVED IN REASONABLY GOOD CONDITION SAVE FOR THE DISTAL MOST PIVOTING ARM SEPARATED FROM THE ASSEMBLY AND THE CAPTIVE LOCKING SCREW AND STUD BROKEN OUT FROM THE WELDMENT. THE REAMING ROD MEASURING DEVICE IS A COMPONENT OF THE TI TROCHANTERIC FIXATION NAIL SYSTEM USED OVER THE REAMING ROD AS AN ALTERNATIVE METHOD FOR MEASURING THE DEPTH FOR AND SELECTING THE CORRECT TI NAIL FOR INTRAMEDULLARY FIXATION OF PROXIMAL FEMUR FRACTURES. THE DEVICE WAS MANUFACTURED JULY 2001, APPROXIMATELY 13 YEARS OLD, HAS LIKELY SUSTAINED MANY FORCED OPENINGS OF THE 3 ARMS AND ULTIMATELY RESULTED IN THE BREAKOUT OF THE WELDED THREADED STUD. THIS LIKELY OCCURRED WHEN FORCED CLOSED/OPEN REPEATEDLY WITHOUT UNLOCKING THE CAPTIVE LOCKING KNOB WHICH IS RECOMMENDED AFTER EACH USE. THE COMPLAINT CONDITION IS CONFIRMED AND THE RISK ASSESSMENT ADEQUATELY ADDRESSED THE COMPLAINT CONDITION. 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.

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT CARR METAL PRODUCTS, INC. MANUFACTURED THE REAMING ROD MEASURING DEVICE, P/N 360.255, AND LOT NUMBER 4287166 ON PO #231389 FOR (B)(4) PIECES DELIVERED JUNE 19, 2001. INITIALLY, THE PART CONFORMED TO THE SUPPLIER¿S CERTIFICATE OF CONFORMANCE, DATED JUNE 14, 2001, AND SYNTHES FINAL INSPECTION SHEET # 360IF255, REVISION ¿A¿. THE PARTS WERE RELEASED TO THE WAREHOUSE ON JULY 6, 2001. MRR #47237 WAS ISSUED JUNE 20, 2001 FOR 6/50 UNITS WITH DIMENSION NONCONFORMANCE; THESE PARTS WERE DISPOSITIONED TO USE AS IS SINCE THE DIMENSION IS A CLEARANCE HOLE; THE MRR WAS CLOSED JULY 3, 2001. THE REAMING ROD MEASURING DEVICE WAS MADE TO THE SYNTHES DRAWING P/N 360.255, REVISION ¿A¿, RELEASED ON JANUARY 18, 2000. 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 A MEASURING DEVICE USED FOR REAMING ROD WAS NOT WORKING PROPERLY. WHILE OPENING OR CLOSING DEVICE, THE NUT WAS NOT LOOSENED AND WAS INSTEAD TORQUED; IT BROKE OFF. SURGEON WAS ABLE TO HOLD AND USE THE TOOL TO COMPLETE THE SURGERY. THERE WAS NO DELAY IN SURGERY, AND NO FRAGMENTS LEFT IN THE PATIENT. THIS IS REPORT NUMBER 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601734 REAMING ROD MEASURING DEVICE MISC ORTHO SURGICAL INSTR LXH SYNTHES MONUMENT 38231389

    Patients

    Seq Age Sex Outcome Treatment
    1