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

Model Number	XBT110195
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Loss of fracture reduction (4901)
Date of Event	05/27/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Physician reported that patient complication was found at first follow-up visit.Post-operative x-rays show reduction loss with advised need for surgical intervention/revision, however, patient elected for no intervention.Patient pain levels are unknown.Current health status of patient is unknown.No further complications were reported.
Additional Manufacturer Narrative
After reviewing all currently available information, we have not been able to determine a definitive root cause.However, because the involvement of our product in the reported issue cannot be ruled out as a potential cause or contributing factor, we are submitting this report in compliance with applicable regulations.Should any new investigative findings emerge that change the conclusions of this report, we will submit a supplemental report accordingly.We will continue to monitor these events as part of post market surveillance activities.
Additional Manufacturer Narrative
During the follow-up interview with the physician, it was identified that implant construct assembly instructions were not followed.This deviation may be associated with the reported adverse event.Product records were reviewed and did not reveal any indication of nonconformance to specifications at the time of manufacture.However, because the involvement of the product in the reported issue cannot be ruled out as a potential cause or contributing factor, this report is being submitted in compliance with applicable regulations.Should new investigative findings emerge that alter the conclusions of this report, a supplemental submission will be provided.We will continue to monitor these events as part of our post-market surveillance activities.
Event or Problem Description
Physician reported that patient complication was found at first follow-up visit.Post-operative x-rays show reduction loss with advised need for surgical intervention/revision, however, patient elected for no intervention.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: 22341064
• Report Number: 3010368646-2025-00001
• Device Sequence Number: 20964145
• Product Code: HSB
• UDI-Device Identifier: 05397283000472
• UDI-Public: (01)05397283000472(17)281221(10)M40339
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K221621
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2025

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: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/26/2025
• Supplement Report FDA Received Date: 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/21/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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 Sex: Male
• Patient Weight: 79 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White