MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SHOULDER INSTRUMENTS; K-WIRE Ø2.5 X 200MM - SF

Model Number	14,00002
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 29 may 2026 lot 2531150: (b)(4) items manufactured and released on 12-dec-2025.Expiration date: 2030-nov-26.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with one similar reported event during the period of review.Considering the semifinished lot (mat82418) of the device involved in this complaint, (b)(4) items were manufactured and released 23-july-2025.To date, four similar events have been reported on the same semifinished lot during the period of review.Root cause: based on the information available, no definitive root cause can be established, while the device history record review does not indicate any potential manufacturing-related issue.Although it cannot be confirmed, the conditions of surgical variation and intraoperative factors (e.G., bone quality, drilling angle, bending/redirection, axial or torsional forces, surgical handling) likely resulted in the applied forces exceeding the inherent limitations of the device resistance as constrained by the collective design inputs.
Event or Problem Description
The k-wire d 2.5 x 200mm broke and was left inside the patient.Patient`s bone quality reported to be normal.

• Brand Name: SHOULDER INSTRUMENTS
• Common Device Name: K-WIRE Ø2.5 X 200MM - SF
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro 6874 ; SZ 6874
• MDR Report Key: 25528753
• Report Number: 3005180920-2026-00564
• Device Sequence Number: 9744145
• Product Code: LXH
• UDI-Device Identifier: 07630971259171
• UDI-Public: 07630971259171
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/17/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 14,00002
• Device Lot Number: 2531150
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2026
• Initial Report FDA Received Date: 06/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown