MAUDE Adverse Event Report: TRIMED, INC. THREADED IM NAIL 1.8MM, 50MM, TI; IMN1.8-50 T

Model Number	IMN1.8-50 T
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Sales manager reported on (b)(6) 2025 that an imn1.8-50 t broke.The rep in the case stated that the surgeon reamed with the appropriate drill prior to putting in the nail beyond where the nail got stuck.As he was advancing the nail he started getting resistance and took an x-ray and saw the nail was bending and tried to back it out at which point the nail broke.The surgeon successfully removed all pieces of the broken device and used a different nail to complete the surgery.The change in inventory caused about a 30-40-minute delay in surgery.

• Brand Name: THREADED IM NAIL 1.8MM, 50MM, TI
• Common Device Name: IMN1.8-50 T
• Manufacturer (Section D): TRIMED, INC.; 27533 avenue hopkins; santa clarita CA 91355
• Manufacturer (Section G): TRIMED, INC.; 27533 avenue hopkins; santa clarita CA 91355
• Manufacturer Contact: megan rissler ; 27533 avenue hopkins; santa clarita, CA 91355
• MDR Report Key: 23844813
• Report Number: 2031009-2025-00027
• Device Sequence Number: 13215789
• Product Code: HWC
• UDI-Device Identifier: 00842188124051
• UDI-Public: 00842188124051
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K211783
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/18/2025

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: IMN1.8-50 T
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2025
• Initial Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Other
• Patient Sex: Unknown