BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK - NAIL HEAD ELEMENTS: TFNA HELICAL BLADE

    MDR report key: 19810722 · Received July 23, 2024

    Report

    Report Number
    8030965-2024-09085
    Event Type
    Malfunction
    Date Received
    July 23, 2024
    Manufacturer
    SYNTHES GMBH
    Product Code
    HSB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H11: ADDITIONAL NARRATIVE: B5: DOI LINK PROVIDED IN EVENT DESCRIPTION CAN BE PASTED INTO AN INTERNET BROWSER TO ACCESS THIS LITERATURE ARTICLE. D1, D2A, D2B, D3, D4, G4 ¿ 510K: THIS REPORT IS FOR AN UNKNOWN NAIL HEAD ELEM: TFNA HELICAL BLADE/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. D9: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. H3, H4, H6: WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. H6 COMPONENT CODES: MOST RELEVANT COMPONENT CODE IS G07002 (APPROPRIATE TERM/CODE NOT AVAILABLE) TO CAPTURE NO FINDINGS AVAILABLE DUE TO NO PRODUCT RETURNED. 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 · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED:OLARTE SALAZAR CM, BURGOS EJ, SÁNCHEZ D, LIBOS A, ARANGO F, TRIANA MÁ, SALAVARRIETA J, PESANTEZ R. OUTCOMES OF CEMENT AUGMENTATION IN FRAGILITY TROCHANTERIC HIP FRACTURES - A MULTICENTER RANDOMIZED CONTROLLED TRIAL FOLLOW-UP. INJURY. 2023 NOV;54 SUPPL 6:110776. DOI: 10.1016/J.INJURY.2023.05.007. EPUB 2023 MAY 2. PMID: 37221112. OBJECTIVE/METHODS/STUDY DATA: THIS MULTICENTER, RANDOMIZED, SINGLE-BLINDED CLINICAL TRIAL AIMED TO EVALUATE EARLY AND LATE POSTOPERATIVE FUNCTIONAL STATUS, QUALITY OF LIFE, AND COMPLICATIONS IN PATIENTS WITH TROCHANTERIC FRACTURES IN ADDITION TO IMPROVEMENT IN FIXATION BY PREVENTING ROTATIONAL AND TRANSLATIONAL MOVEMENT OF THE IMPLANT WITHIN THE FEMORAL HEAD. BETWEEN SEPTEMBER 2015 AND DECEMBER 2017, A TOTAL OF 90 PATIENTS WERE INCLUDED IN THE STUDY, BUT ONLY 53 PATIENTS (42 FEMALES AND 11 MALES) COMPLETED THE FOLLOW-UP. AMONG THESE, 30 PATIENTS (7 MALE AND 23 FEMALE; MEAN AGE OF 83.87 YEARS) WERE INCLUDED IN THE CONTROL GROUP (NO AUGMENTATION) AND 23 PATIENTS (4 MALE AND 19 FEMALE; MEAN AGE OF 85.(B)(6) YEARS) WERE INCLUDED IN THE INTERVENTION GROUP (AUGMENTATION). SURGERY WAS PERFORMED USING TFNA [TROCHANTERIC FIXATION NAIL] ¿ ADVANCED; DEPUY SYNTHES). THE CONTROL GROUP RECEIVED THE STANDARD TREATMENT (REDUCTION AND INTERNAL FIXATION), WHILE THE INTERVENTION GROUP WAS TREATED WITH REDUCTION AND INTERNAL FIXATION PLUS AUGMENTATION WITH POLYMETHYLMETHACRYLATE (PMMA), TRAUMACEM V+ (DEPUY SYNTHES, WEST CHESTER, PA, USA). LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: UNKNOWN DEPUY SYNTHES TROCHANTERIC FIXATION NAIL ¿ ADVANCED (TFNA) AND TRAUMACEM V+. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - CONSTRUCTS: TFNA (QTY 13) 10 PATIENTS HAD READMISSIONS DUE TO NON-FRACTURE-RELATED COMPLICATION SUCH AS VERTEBRAL FRACTURE, STROKE, BRONCHITIS, CHRONIC RESPIRATORY INSUFFICIENCY, URINARY TRACT INFECTION, ACUTE MYOCARDIAL INFARCTION, PNEUMONIA ,PYELONEPHRITIS, PNEUMONIA/BIOCHEMICAL IMBALANCE, GASTROINTESTINAL BLEEDING 3 PATIENTS HAD READMISSION DUE TO FRACTURE RELATED COMPLICATIONS SUCH AS ANEMIA, SURGICAL SITE INFECTION AND DEEP VEIN THROMBOSIS; NO INTERVENTION WAS NOTED ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - BIOMATERIAL - CEMENT: TRAUMACEM (QTY 1) - IT WAS NOT SPECIFIED WHICH GROUP THE EVENTS BELOW OCCURRED: 10 PATIENTS HAD READMISSIONS DUE TO NON-FRACTURE-RELATED COMPLICATION SUCH AS VERTEBRAL FRACTURE, STROKE, BRONCHITIS, CHRONIC RESPIRATORY INSUFFICIENCY, URINARY TRACT INFECTION, ACUTE MYOCARDIAL INFARCTION, PNEUMONIA ,PYELONEPHRITIS, PNEUMONIA/BIOCHEMICAL IMBALANCE, GASTROINTESTINAL BLEEDING 3 PATIENTS HAD READMISSION DUE TO FRACTURE RELATED COMPLICATIONS SUCH AS ANEMIA, SURGICAL SITE INFECTION AND DEEP VEIN THROMBOSIS; NO INTERVENTION WAS NOTED ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - NAIL HEAD ELEMENTS: TFNA HELICAL BLADE (QTY 2) 1 PATIENT FROM THE CONTROL GROUP HAD A CUT-THROUGH ONE MONTH AFTER THE INTERVENTION. 1 PATIENT FROM THE INTERVENTION GROUP HAD A CUT THROUGH 18 MONTHS AFTER THE PROCEDURE. THIS REPORT INVOLVES ONE UNK - NAIL HEAD ELEM: TFNA HELICAL BLADE. THIS IS REPORT 3 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2472209 UNK - NAIL HEAD ELEMENTS: TFNA HELICAL BLADE ROD, FIXATION, INTRMEDULLARY AND ACCESSORIES HSB SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown