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	06/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Thek-wire d 2.5 x 200 mm broke during reaming of the central glenoid peg.It is possible that the reaming was not properly aligned during the preparation of this peg.It was not possible to retrieve the broken fragment of the k-wire (approximately 2 cm long) despite several attempts.The surgeon completed the procedure and successfully implanted the shoulder prosthesis in the patient.
Additional Manufacturer Narrative
Clinical evaluation performed by clinical affair manager during surgery, the k-wire broke during reaming of the central glenoid peg.Based on the information provided, it is possible that suboptimal alignment during the preparation of the glenoid peg contributed to increased mechanical stress on the k-wire, ultimately leading to its failure.Multiple attempts were made to retrieve the broken fragment; however, these were unsuccessful, and an approximately 2 cm portion of the k-wire remains in situ.Despite this event, the surgeon was able to complete the procedure without further complications, and the shoulder prosthesis was successfully implanted.It should be noted that the instruments are manufactured from surgical-grade stainless steel, which is designed for temporary intraoperative use and is not approved for long-term implantation.In rare cases, fragments of broken surgical instruments may remain in the body.The occurrence of adverse reactions associated with retained metallic fragments is considered extremely uncommon.In such situations, the surgeon must rely on their clinical judgment to determine the most appropriate course of action, taking into account the risks and benefits for the patient.The decision to leave the fragment in place is typically based on the potential risks associated with retrieval versus the likelihood of harm from retention.Continuous postoperative monitoring is recommended to ensure patient safety and to promptly identify any potential complications, although none are expected based on current evidence and the outcome of the procedure.Batch review performed on 02 jun 2026 lot 2607890: (b)(4) items manufactured and released on 30-apr-2026.Expiration date: 2031-apr-12.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Considering the semifinished lot (mat74275) of the device involved in this complaint, (b)(4) items were manufactured and released 24-jul-2025.To date, one similar event has been reported on the same semifinished lot during the period of review.Investigation performed by r&d project manager the provided picture confirms the breakage of the k-wire indicatively at 2-3 cm from the tip.Malalignment while drilling for the central post may have contributed to increase the stresses at the tip of the central peg reamer resulting in the k-wire failure.Although it may not be directly related to the reported event, r&d is investigating a potential improvement the device reliability.Root cause: 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.The investigation does not indicate any potential manufacturing related issue or systemic deficiency.

• 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: 25663782
• Report Number: 3005180920-2026-00574
• Device Sequence Number: 5596164
• 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): 06/30/2026

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: 2607890
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2026
• Initial Report FDA Received Date: 06/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2026
• 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 Age: 68 YR
• Patient Sex: Female