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) manufactured and released on 12-dec-2025.Expiration date: 2030-nov-26.No anomalies found related to the problem.To date, 66 items of the same lot have been sold with no similar reported event during the period of review.Considering the semifinished lot (mat82418) of the device involved in this complaint, (b)(4) were manufactured and released 23-july-2025.To date, three similar events have been reported on the same semifinished lot during the period of review.Clinical evaluation performed by clinical affairs manager a k-wire d 2.5 x 200 mm fractured during use and a fragment remains inside the patient.The wire is currently stuck within the bone and cannot be removed.According to the surgeon, the patient`s bone quality was normal.Based on the available information and imaging, the retained fragment does not appear to interfere with the prosthesis.The pin remains embedded in the bone and no safe removal option has been identified.It should be noted that the evaluation is limited by the availability of a single radiographic image of poor resolution.As only one projection is available, it is not possible to clearly determine the exact position and orientation of the retained fragment.Therefore, the assessment relies on the information provided.The instrument is manufactured from surgical-grade stainless steel; however, it is not approved for long-term implantation.In rare cases, fragments of broken instruments may be left in the body.The occurrence of adverse reactions in such situations is extremely uncommon.Nevertheless, the surgeon must exercise their best clinical judgment in determining the appropriate course of action in the interest of the patient`s health.Root cause:although the specific circumstances 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.The investigation does not indicate any potential manufacturing related issue or systemic deficiency.
Event or Problem Description
The k-wire d 2.5 x 200mm broke and was left inside the patient as it is stuck in the bone and cannot be removed.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: 25529110
• Report Number: 3005180920-2026-00558
• Device Sequence Number: 15857225
• 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 Age: 79 YR
• Patient Sex: Male
• Patient Weight: 65 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White