UNK - Nails: Expert Tibial

Description of Event or Problem

This complaint is from a literature source. The following literature cite has been reviewed:Stuckman SA, Bair JM, Georgiadis GM. Late Complication From Dislodgement of the Expert Tibial Nailing System Internal Locking Sleeve: A Case Report. JBJS Case Connect. 2025 Jul 3;15(3). doi: 10.2106/JBJS.CC.25.00013. PMID: 40608950.OBJECTIVE/METHODS/STUDY DATA: A 46-year-old woman slipped and fell on ice in February of 2022 sustaining a closed spiral fracture of her right distal tibia, 42B1 by the Arbeitsgemeinschaft fur Osteosynthesefragen/Orthopaedic Trauma Association (AO/OTA) classification. A preoperative computerized tomography (CT) scan was performed. This revealed as mall, non-displaced Bartonicek type 2 posterior malleolus fracture. The patient was taken to the operating theater the day after injury and was treated with an Expert Tibial Nail. The patient had an uneventful postoperative course. One year after her initial surgery she presented with warmth, pain, erythema, and drainage at the fracture site. She was diagnosed with a deep infection at the fracture site. the fracture site and promptly taken to the operating room. The fracture site was accessed by a large anteromedial approach. Purulence was found, and a portion of the plastic sleeve from the end of the nail was embedded in the fracture site. Additional fragments of plastic were found in the soft tissues. All foreign material was removed along with a wide ellipse of bone, followed by nail removal and intramedullary reaming. Antibiotic therapy was instituted. Her cultures grew a methicillin-sensitive Staphylococcus aureus species. She had a peripherally inserted central catheter placed and originally was treated with intravenous cefazolin. After 3 weeks, she developed a rash and was switched to intravenous vancomycin for another 3 weeks. Her anteromedial wound healed. No other antibiotics were given. One year after nail removal (2 years after original injury), the patient was ambulatory without assistive devices or a limp. She had no pain and had recovered full function.Lot, Model and Catalog number are not available, but the suspected DePuy Synthes device(s) possibly associated with reported adverse events: UNK - Constructs: Expert Tibial Nail.ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS possibly associated with UNK - Constructs: Expert Tibial Nail (Qty =1):A 46-year-old woman with a closed spiral fracture of her right distal tibia was treated with an Expert Tibial Nail initially. One year after her initial surgery she presented with warmth, pain, erythema, and drainage at the fracture site. Antibiotic therapy was instituted. Her cultures grew a methicillin-sensitive Staphylococcus aureus species. She had a peripherally inserted central catheter placed and originally was treated with intravenous cefazolin. After 3 weeks, she developed a rash and was switched to intravenous vancomycin for another 3 weeks. Her anteromedial wound healed.ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS possibly associated UNK - Nails: Expert Tibial (Qty =1):Dislodgement of the polymer insert (N = 1) Treatment: Nail removal and intramedullary reaming.

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.If information is obtained that was not available for the initial MedWatch, a Follow-up MedWatch will be filed as appropriate.D4: UDI: As the catalog/model number was not provided, the (01) GTIN is not available.