BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11.0MM TI HELICAL BLADE 95MM

    MDR report key: 5815917 · Received July 22, 2016

    Report

    Report Number
    3003506883-2016-10125
    Event Type
    Injury
    Date Received
    July 22, 2016
    Report Date
    July 9, 2016
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HSB
    PMA / PMN Number
    K011857
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DATE OF EVENT: UNKNOWN DATE. ADDITIONAL CODE: HWC. (B)(4). ORIGINAL IMPLANT DATE IS UNKNOWN. 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 RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS LOT# 9864866 OF 11.0MM TI HELICAL BLADE 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 (7950334) MET ALL SPECIFICATIONS. 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)(6). PRODUCT INVESTIGATION SUMMARY: THIS COMPLAINT IS UNCONFIRMED AS NO VISUAL EVIDENCE (NO X-RAYS NOR POST-OPERATIVE MEDIAL MIGRATION IMAGES) WERE PROVIDED TO CONFIRM MEDIAL MIGRATION. WHETHER THIS COMPLAINT CAN BE REPLICATED IS NOT APPLICABLE. A VISUAL INSPECTION UNDER 5X MAGNIFICATION, A DEVICE HISTORY RECORD (DHR) REVIEW, AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. FURTHER, PART 04.005.524 (LOT NUMBER UNKNOWN) WAS RETURNED AS A CONCOMITANT DEVICE WITHOUT AN ALLEGED COMPLAINT CONDITION. UPON VISUAL INSPECTION, THERE WAS NO EVIDENCE THAT THIS DEVICE CONTRIBUTED TO THE COMPLAINT CONDITION; THEREFORE, NO ADDITIONAL INVESTIGATION WILL BE PERFORMED. THE ENGINEERING INVESTIGATION SHOWS THAT THIS IMPLANT IS PART OF THE TITANIUM TROCHANTERIC FIXATION NAIL (TFN) SYSTEM INTENDED FOR THE INTRAMEDULLARY FIXATION OF PROXIMAL FEMUR FRACTURES. THE HELICAL BLADE WAS RECEIVED WITH WEAR AND DAMAGE (I.E. DENTS) CONSISTENT WITH IMPLANTATION AND EXPLANTATION. A REVIEW OF THE CURRENT DESIGN DRAWING WAS PERFORMED. DURING THE INVESTIGATION, HOWEVER, NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. THE RETURNED PART WAS DETERMINED TO BE SUITABLE FOR THE INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED. ALTHOUGH THE MANUFACTURE IS UNABLE TO DETERMINE A DEFINITIVE ROOT CAUSE, IT IS NOT LIKELY THE RESULT OF THE DESIGN OF THE DEVICE. NO NEW, UNIQUE, OR DIFFERENT PATIENT HARMS WERE IDENTIFIED AS A RESULT OF THIS EVALUATION. THE RETURNED PART WAS DETERMINED TO BE SUITABLE FOR THE INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED. 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

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(4). 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 THE PATIENT WAS IMPLANTED WITH A 95MM HELICAL BLADE ON AN UNKNOWN DATE. THE ORIGINAL IMPLANTED 95MM HELICAL BLADE HAD PROTRUDED MEDIALLY THROUGH THE FEMORAL HEAD ON AN UNKNOWN DATE. ON (B)(6) 2016, THE SURGEON PERFORMED A REVISION OF THE RIGHT-SIDE CEPHALOMEDULLARY ROD PROCEDURE ON THE PATIENT, EXTRACTING THE 95MM HELICAL BLADE ON A TROCHANTERIC FIXATION NAIL (TFN) CONSTRUCT, INTRAMEDULLARY (IM) LOCKING SCREW DISTALLY AND IMPLANTED A 80MM HELICAL BLADE. THE PATIENT STATUS / OUTCOME IS UNKNOWN. IT WAS REPORTED THAT THERE WAS NO SURGICAL DELAY AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. CONCOMITANT DEVICES REPORTED: TITANIUM (TI) LOCKING SCREW (PART # 04.005.524, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468356 11.0MM TI HELICAL BLADE 95MM ROD,FIXATION,INTRAMEDULLARY HSB SYNTHES ELMIRA 9864866

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention