BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    14MM/130 DEG TI CANN TROCH FIXATION NAIL 420MM/LEFT-STER

    MDR report key: 3983357 · Received August 6, 2014

    Report

    Report Number
    1719045-2014-10351
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Date of Event
    July 8, 2014
    Report Date
    July 8, 2014
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    PK011857
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT CODE: HWC. DEVICE WAS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    (B)(4): A REVIEW OF DEPUY SYNTHES MONUMENT DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES.DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSISIF 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.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 DURING A TROCHANTERIC FIXATION NAIL PROCEDURE, A 120 MM HELICAL BLADE WOULD NOT INSERT. IT WAS CATCHING ON THE NAIL; THE TIP ENDED UP BEING BENT AND WAS NOT IMPLANTED IN THE PATIENT. IT IS POSSIBLE THAT INCISION SITE FOR HELICAL BLADE WAS IN WRONG PLACE. SO THE INSERTION HANDLE WAS PULLED TO COMPENSATE THE SOFT TISSUE STRETCH AND GET THE CORRECT ANGLE. THE SOFT TISSUE PULLED THE COMPRESSION SLEEVE SO IT DID NOT LINE UP. A LAG SCREW WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A REPORTED SURGICAL DELAY OF TWO MINUTES AND THE SURGERY WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME WAS REPORTED AS FINE. THIS IS REPORT 1 OF 8 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460313 14MM/130 DEG TI CANN TROCH FIXATION NAIL 420MM/LEFT-STER ROD, FIXATION, INTRAMEDULLARY HSB SYNTHES MONUMENT 7496643

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR