BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    11.0MM TI TROCH FIXATION NAIL SCREW/95MM - STERILE

    MDR report key: 4223069 · Received November 4, 2014

    Report

    Report Number
    1719045-2014-10553
    Event Type
    Malfunction
    Date Received
    November 4, 2014
    Report Date
    October 7, 2014
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    PK092646
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: A PRODUCT EVALUATION WAS PERFORMED. THE INVESTIGATION OF THE COMPLAINT ARTICLES INDICATES THAT: THE 11.0MM TI TROCHANTERIC FIXATION SCREW IS FOUND IN THE TITANIUM TROCHANTERIC FIXATION NAIL SYSTEM FOR INTRAMEDULLARY FIXATION OF FEMUR FRACTURES. THE TECHNIQUE GUIDE WAS REVIEWED FOR THE PROPER USE OF THIS DEVICE (J3900-I). ONE 11.0MM TI TROCHANTERIC FIXATION SCREW (PART # 04.032.095, LOT #7596990, MFG FEB 2014) WAS RETURNED WITH THE COMPLAINT THAT ¿A BROKEN LAG SCREW FROM A TNF WAS FOUND BY THE SALES CONSULTANT WHILE DOING HIS ROUNDS IN THE HOSPITAL. THE BROKEN DEVICE WAS FOUND IN A ¿PILL PACK BAG¿ USED DURING STERILIZATION.¿ UPON RECEIPT OF THE DEVICE IT WAS SEEN THAT A SECTION CONTAINING SIX LEVELS OF THE DISTAL THREADS HAS BROKEN OFF AND THE RETURNED PART IS IN TWO PIECES, WITH DISCOLORATION AND DISTINCT MARKINGS ON THE DISTAL THREADING, THIS COMPLAINT IS CONFIRMED. IT IS NOT KNOWN WHAT CAUSED THIS COMPLAINT CONDITION, OR WHAT PARAMETERS IT WAS EXPOSED TO, THE ROOT CAUSE IS INDETERMINATE. THE DRAWING FOR THIS IMPLANT (04_032_070 REV D) WAS REVIEWED, AND THE DESIGN, MATERIAL, AND FINISHING PROCESSES WERE SEEN TO BE ADEQUATE FOR ITS INTENDED USE. 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

    ADDITIONAL PRODUCT CODE: HWC. IT IS UNKNOWN IF THE DEVICE WAS IMPLANTED/EXPLANTED. 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 DEPUY SYNTHES MONUMENT DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES. 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 BROKEN LAG SCREW FROM A TROCHANTERIC FIXATION NAIL WAS IN A PILL PACK BAG USED DURING STERILIZATION. NO FURTHER INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705695 11.0MM TI TROCH FIXATION NAIL SCREW/95MM - STERILE ROD, FIXATION, INTRAMEDULLARY HSB SYNTHES MONUMENT 7596990

    Patients

    Seq Age Sex Outcome Treatment
    1