BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROD, FIXATION, INTRAMEDUALLARY

    MDR report key: 6270841 · Received January 23, 2017

    Report

    Report Number
    2520274-2017-10225
    Event Type
    Injury
    Date Received
    January 23, 2017
    Report Date
    January 16, 2017
    Manufacturer
    SYNTHES USA
    Product Code
    HSB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT FOR DIAGNOSIS. DATE OF EVENT: FLORES, S; WOOLRIDGE, A; CAROOM, C; AND JENKINS, M. (2016) THE UTILITY OF THE TIP¿APEX DISTANCE IN PREDICTING AXIAL MIGRATION AND CUTOUT WITH THE TROCHANTERIC FIXATION NAIL SYSTEM HELICAL BLADE. J ORTHO TRAUM, VOL 30:6, E207-E211. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. 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

    THIS REPORT IS BEING FILED AFTER SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE: FLORES, S; WOOLRIDGE, A; CAROOM, C; AND JENKINS, M. (2016) THE UTILITY OF THE TIP¿APEX DISTANCE IN PREDICTING AXIAL MIGRATION AND CUTOUT WITH THE TROCHANTERIC FIXATION NAIL SYSTEM HELICAL BLADE. J ORTHO TRAUM, VOL 30:6, E207-E211. THE PURPOSE OF THE RETROSPECTIVE STUDY WAS TO EVALUATE THE MECHANICAL COMPLICATIONS ASSOCIATED WITH THE HELICAL BLADE DESIGNED IMPLANT OF THE TROCHANTERIC FIXATION NAIL (TFN) SYSTEM ((B)(4)), PARTICULARLY WITH REGARD TO AXIAL MIGRATION AND CUTOUT, AND FURTHERMORE TO DETERMINE THE UTILITY OF THE TIP-APEX DISTANCE (TAD) IN PREDICTING THIS COMPLICATION. FOUR HUNDRED FORTY-THREE PATIENTS SURGICALLY TREATED FOR PROXIMAL FEMUR FRACTURES WERE IDENTIFIED THROUGH A QUERY OF CURRENT PROCEDURAL TERMINOLOGY (CPT) CODE 27245 FROM JANUARY 2009 TO FEBRUARY 2013. A TOTAL OF 258 PATIENTS TREATED WITH THE TFN HELICAL BLADE SYSTEM WERE INCLUDED IN THE STUDY. ONE HUNDRED FIFTY-EIGHT PATIENTS WERE FEMALE AND A HUNDRED WERE MALE. THE MEAN AGE WAS 77 YEARS. AVERAGE FOLLOW-UP WAS 6.5 MONTHS USING THE ARBEITSGEMEINSCHAFT FUR OSTEOSYNTHESEFRAGEN/ ORTHOPEDIC TRAUMA ASSOCIATION (AO/OTA) CLASSIFICATION SYSTEM, 137 FRACTURES WERE STABLE AND 121 WERE UNSTABLE. THE AVERAGE TAD WAS 20.4 MM (RANGE 3.8¿41.56 MM). THE OVERALL RATE OF MECHANICAL COMPLICATIONS WAS 10.1%. AXIAL MIGRATION WITH PERFORATION OCCURRED IN 8 PATIENTS. AXIAL MIGRATION ONLY UP TO SUBCHONDRAL BONE WITHOUT PERFORATION OCCURRED IN 3 PATIENTS. OF THE 8 PATIENTS WITH FEMORAL HEAD AXIAL PERFORATIONS, 7 REQUIRED REVISION SURGERY, WITH 3 PATIENTS REQUIRING MULTIPLE REVISION PROCEDURE INCLUDING ONE PATIENT REQUIRING EVENTUAL TOTAL HIP ARTHROPLASTY AND ANOTHER PATIENT REQUIRING A GIRDLESTONE PROCEDURE. ONE PATIENT AND THEIR FAMILY ELECTED TO SIMPLY LIVE WITH LIMITED WEIGHT BEARING AND NOT PROCEED WITH ANY ADDITIONAL REVISION PROCEDURES. SYMPTOMATIC LATERAL MIGRATION OCCURRED IN 11 PATIENTS, ALTHOUGH ONLY 1 REQUIRED A REVISION PROCEDURE. THREE FRACTURES OCCURRED AT THE DISTAL TIP OF THE NAIL (1.1%). ONE FRACTURE FAILED IN VARUS COLLAPSE AND CUTOUT. A TAD <20 MM WAS ASSOCIATED WITH AN INCREASED FREQUENCY OF AXIAL MIGRATION AND CUTOUT WITH THE TFN HELICAL BLADE. THIS REPORT IS 3 OF 14 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN TFN SYSTEM AND REFERS TO THE SERIOUS INJURY / REPORTABLE MALFUNCTION OF CASE 3, (B)(6) MALE WHO EXPERIENCED RATION, AXIAL CUTOUT AND REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54221 ROD, FIXATION, INTRAMEDUALLARY HSB SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR Required Intervention