UNK - Nails: TFNA

Description of Event or Problem

This complaint is from a literature source. The following literature cite has been reviewed:Cheng-Chun Chung, Chih-Ting Cheng, Chun-Chieh Lin, Ting Lin, Hsu-Wei Fange, Yung-Chang Lu, Tsung-Yu Lin; Cephalomedullary Nail and Cement Augmentation Outcome Analysis in Geriatric Intertrochanteric Fractures; International Journal of Gerontology 20 (2026) 139 144; (Pubmed cite not available).OBJECTIVE/METHODS/STUDY DATA: The aim of this study is to compare the functional outcomes and mechanical complication rates of PFNA-II and TFNA, and to assess the impact of TFNA cement augmentation in geriatric patients with osteoporotic IT fractures. Between 2019 and 2023, 469 patients were retrospectively classified into three groups: PFNA-II (n = 224), TFNA without cement (n = 104), and TFNA with cement augmentation (n = 141), (males:182, females: 287), overall mean age is 82.2 ± 8.5. Short nails (PFNA-II: 200 and 240mm; TFNA: 200 and 235mm) were used via the standard reduction technique on a fracture table in supine position. All selected implants had the same caput-column diaphyseal angle of 130. To enhance stability, polymethylmethacrylate cement augmentation (DePuySynthes, Oberdorf, Basel Landschaft, Switzerland) was used in the femoral head for the TFNA cement group but not in the PFNA-II group due to design limitations. Mean follow-up was 40.2 ± 10.4 weeks.Lot, Model and Catalog number are not available, but the suspected Deputy Synthes device(s) possibly associated with reported adverse events: UNK - Constructs: PFNA-II and UNK - Constructs: TFNA.Other Devices that were used on the patient at the time of the event: Polymethylmethacrylate cement augmentationADVERSE EVENT(S) AND PROVIDED INTERVENTIONS possibly associated with UNK - Constructs: PFNA-II (Qty =2):Periprosthetic fracture (N=2) Treatment: Not reportedADVERSE EVENT(S) AND PROVIDED INTERVENTIONS possibly associated with UNK - Constructs: TFNA (Qty =1):Periprosthetic fracture (N=1) Treatment: Not reported.ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS possibly associated UNK - Nails: PFNA-II (Qty =12):Cut-out (N=4) Treatment: Not reportedCut-through (N=2) Treatment: Not reportedLateral migration (N=5) Treatment: Not reportedImplant breakage (N=1) Treatment: Not reported.ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS possibly associated UNK - Nails: TFNA (Qty =10:Cut-out (N=4) Treatment: Not reportedCut-through (N=2) Treatment: Not reportedLateral migration (N=3) Treatment: Not reportedImplant breakage (N=1) Treatment: Not reported.ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS possibly associated UNK - Nail Head Elem: TFNA (Qty =1):An 88-year-old female with a 31-A2 fracture and a BMD T-score of-2.8, underwent fixation with TFNA without cement augmentation. 1 month postoperatively showing lateral migration.ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS possibly associated UNK - Nail Head Elements: PFNA-II Blade (Qty =1):An 86-year-old male with a BMDT-scoreof-2.6suffered from31-A2fracture and underwent PFNA-II fixation. Radiograph postoperatively showed cut-out, lateral migration, and periprosthetic fracture. Revision surgery with cemented bipolar hemiarthroplasty.ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS possibly associated UNK - Biomaterial - Cement (Qty =1):Periprosthetic fracture (N=1) Treatment: Not reported.

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (b)(4)This report is being submitted pursuant to the provisions of 21 CFR, Part 803 (and/or Part 4, as applicable). This report may be based on information which has not been investigated or verified prior to the required reporting date. This report does not reflect a conclusion by DePuy Synthes, or its employees that the report constitutes an admission that the product, DePuy Synthes, or its employees caused or contributed to the potential event described in this report. Additional Narrative:D4: UDI: As the catalog/model number was not provided, the (01)GTIN is not available.If information is obtained that was not available for the initial MedWatch, a Follow-up MedWatch will be filed as appropriate.