BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROD,FIXATION,INTRAMEDULLARY

    MDR report key: 6647578 · Received June 16, 2017

    Report

    Report Number
    2520274-2017-11815
    Event Type
    Malfunction
    Date Received
    June 16, 2017
    Report Date
    June 1, 2017
    Manufacturer
    SYNTHES (USA)
    Product Code
    HSB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. CHO, H.M., ET AL. (2016). CLINICAL AND FUNCTIONAL OUTCOMES OF TREATMENT FOR TYPE A1 INTERTROCHANTERIC FEMORAL FRACTURE IN ELDERLY PATIENTS: COMPARISON OF DYNAMIC HIP SCREW AND PROXIMAL FEMORAL NAIL ANTIROTATION, HIP PELVIS 28(4): 232-242. THIS REPORT IS FOR AN UNKNOWN PFNA HELICAL BLADE, UNKNOWN QUANTITY # / UNKNOWN LOT #. (OTHER NUMBER) UDI # UNKNOWN PART NUMBER, UDI IS UNAVAILABLE. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT 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 THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE: CHO, H.M., ET AL. (2016). CLINICAL AND FUNCTIONAL OUTCOMES OF TREATMENT FOR TYPE A1 INTERTROCHANTERIC FEMORAL FRACTURE IN ELDERLY PATIENTS: COMPARISON OF DYNAMIC HIP SCREW AND PROXIMAL FEMORAL NAIL ANTIROTATION, HIP PELVIS 28(4): 232-242, 2016. KOREA. THE STUDY OBJECTIVE WAS TO EVALUATE AND COMPARE THE CLINICAL AND FUNCTIONAL OUTCOMES OF DYNAMIC HIP SCREW (DHS) AND PROXIMAL FEMORAL NAIL ANTIROTATION (PFNA) TREATMENT OF AO TYPE 1 INTERTROCHANTERIC FRACTURES IN ELDERLY PATIENTS. THE STUDY INCLUDED PATIENTS WITH INTERTROCHANTERIC FEMORAL FRACTURE BETWEEN JANUARY 2004 AND DECEMBER 2014, THOSE YOUNGER THAN 70 YEARS, WITH AO FRACTURE CLASSIFICATION OF TYPE 2 OR HIGHER7), WITH BILATERAL FRACTURE. 113 CASES TREATED WITH DHS (DHS GROUP), AND 81 CASES TREATED WITH PFNA (PFNA GROUP). REGARDING THE DHS AND PFNA GROUPS, RESPECTIVELY: MEAN PATIENT AGE, 84.2 (70- 93) YEARS AND 81.0 (70-94) YEARS. DHS GROUP RECEIVED A 135 DEGREE-ANGLED PLATE AND HIP SCREWS. THE REDUCTION METHOD USED FOR THE PFNA GROUP WAS SIMILAR TO THAT USED FOR DHS GROUP. AFTER REAMING THE LATERAL CORTEX, A HELICAL BLADE WAS INSERTED, FOLLOWED BY THE INSERTION OF DISTAL LOCKING SCREWS. THE SIZE OF THE NAIL WAS DETERMINED BASED ON THE PREOPERATIVE RADIOGRAPHS, AND, FOR ALL PATIENTS, THE NECK-SHAFT ANGLE WAS 130 DEGREES, WITH A LENGTH OF 170MM OR 200MM. THE FOLLOWING COMPLICATIONS WERE REPORTED: IN THE PFNA GROUP, HELICAL BLADE CUT-THROUGH INTO THE FEMORAL HEAD WAS SUSPECTED IN ONE PATIENT; HOWEVER, NO REVISION SURGERY OR ADDITIONAL TREATMENT WAS PERFORMED, BECAUSE UNION OCCURRED WITHOUT HEAD PENETRATION. IN THE PFNA GROUP, PATIENTS EXPERIENCED SLIDING. IN ADDITION, TWO PATIENTS HAD FEMORAL HEAD SCREW (HELICAL BLADE) CUT-THROUGH. THIS IS REPORT 8 OF 8 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN QUANTITY OF PFNA HELICAL BLADE, UNKNOWN PART # / LOT #.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427804 ROD,FIXATION,INTRAMEDULLARY HSB SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1