BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI SPIRAL BLADE 40MM FOR TI HUMERAL NAILS

    MDR report key: 4788887 · Received May 21, 2015

    Report

    Report Number
    3003506883-2015-10083
    Event Type
    Injury
    Date Received
    May 21, 2015
    Report Date
    April 30, 2015
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    JDS
    PMA / PMN Number
    PK992348
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: PATIENT WEIGHT IS UNKNOWN. EVENT DATE: UNKNOWN WHEN THE NAIL BROKE. (B)(4). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS LOT 6830855 OF TI SPIRAL BLADE 40MM WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NONCONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF MANUFACTURE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORD REVEALED THIS LOT (6664549) MET ALL SPECIFICATIONS EXCEPT THAT THE ENDS OF THE BARS WERE PAINTED. BOTH LEADING AND REMNANT ENDS OF THE BAR ARE CUT OFF AND DISCARDED, SO THIS ANOMALY HAD NO EFFECT ON FINAL PRODUCT. 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 (B)(6) FEMALE PATIENT PRESENTED WITH A BROKEN HUMERAL NAIL. THE PATIENT WAS ORIGINALLY IMPLANTED (B)(6) 2012. ON (B)(6) 2015, THE PATIENT UNDERWENT HARDWARE REMOVAL: NAIL, END-CAP, TWO LOCKING SCREWS AND SPIRAL BLADE. ANTIBIOTIC CEMENT BEADS WERE PLACED FOR POSSIBLE INFECTION. PATIENT STATUS WAS REPORTED AS OKAY. THE PROVIDED X-RAY WAS REVIEWED BY THE MANUFACTURER AND IT WAS NOTED THAT THE NAIL BREAKAGE COULD BE CONFIRMED. THIS IS REPORT 2 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333553 TI SPIRAL BLADE 40MM FOR TI HUMERAL NAILS NAIL, FIXATION, BONE JDS SYNTHES ELMIRA 6830855

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention