MAUDE Adverse Event Report: X-BOLT ORTHOPEDICS PRO-X1 TROCHANTERIC NAIL; INTRAMEDULLARY FIXATION ROD

Model Number	XBT110195
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Joint Impingement (4834); Loss of fracture reduction (4901)
Date of Event	10/23/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Post-operative radiographs reviewed during the investigation demonstrated suboptimal fracture reduction, which is consistent with a procedural rather than device-related factor.The patient also reported multiple falls prior to presentation to the emergency department, representing a patient-related factor that may have influenced the clinical outcome.A device-related contribution to the reported event could not be conclusively excluded based on the information available; therefore, we are submitting this report in accordance with 21 cfr part 803.If additional information becomes available that materially impacts the assessment, a supplemental report will be submitted.We will continue to monitor this and similar events through established post-market surveillance processes.
Event or Problem Description
Patient required removal of implant and revision surgery to convert femoral nail implant to hemiarthroplasty due to loss of fracture reduction and joint impingement.Implant was intact when patient presented for the revision surgery.Patient pain levels are unknown.Current health status of patient is unknown.No further complications were reported.

• Brand Name: PRO-X1 TROCHANTERIC NAIL
• Common Device Name: INTRAMEDULLARY FIXATION ROD
• Manufacturer (Section D): X-BOLT ORTHOPEDICS; northwood court; unit 5; dublin, co. dublin D09AX 54; EI D09AX54
• Manufacturer Contact: naser rahman ; northwood court; unit 5; dublin, co. dublin D09AX-54 ; EI D09AX54
• MDR Report Key: 23629326
• Report Number: 3010368646-2025-00003
• Device Sequence Number: 9337571
• Product Code: HSB
• UDI-Device Identifier: 05397283000472
• UDI-Public: (01)05397283000472(17)281221(10)M40339
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K221621
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/21/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: XBT110195
• Device Catalogue Number: XBT110195
• Device Lot Number: M40339
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2025
• Initial Report FDA Received Date: 11/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 85 YR
• Patient Sex: Female