BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11.0MM TI HELICAL BLADE 105MM-STERILE

    MDR report key: 4301010 · Received December 5, 2014

    Report

    Report Number
    3003506883-2014-10155
    Event Type
    Injury
    Date Received
    December 5, 2014
    Report Date
    November 7, 2014
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HSB
    PMA / PMN Number
    PK011857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: PATIENT¿S INITIALS ARE (B)(6). DEVICE 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 NARRATIVE: 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

    EXPIRATION DATE: REPORTED AS JUNE 2021. 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 IT REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS LOT 6982978 OF 11.0MM TI HELICAL BLADE 105MM STERILE 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 DETERMINED THE RAW MATERIAL LOT 6816201 MET ALL SPECIFICATIONS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 POST IMPLANTATION OF A TFN (TROCHANTERIC FIXATION NAIL) SYSTEM, THE PATIENT WAS EXPERIENCING SIGNIFICANT PAIN AND A DECLINE IN RANGE OF MOTION IN THE EFFECTED HIP. THE REVISION SURGERY WAS DONE APPROXIMATELY 2 YEARS POST INITIAL IMPLANT. DURING THE REVISION SURGERY, WHICH WAS PLANNED AS A CONVERSION TO TOTAL JOINT HIP REPLACEMENT, THE HELICAL BLADE WENT THROUGH THE FEMORAL HEAD. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH OUT DELAY AND/OR ADDITIONAL MEDICAL/SURGICAL INTERVENTION. THE PATIENT OUTCOME WAS GOOD AND IT WAS REPORTED THAT THE PATIENT HAS REESTABLISHED WALKING SUCCESSFULLY. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788059 11.0MM TI HELICAL BLADE 105MM-STERILE ROD, FIXATION, INTRAMEDULLARY HSB SYNTHES ELMIRA 6982978

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention