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

Model Number	14,00002
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
While drilling the central hole for the baseplate component, the k-wire fractured.The broken fragment could not be retrieved, and the surgeon decided to leave the fragment in the patient.The surgery was prolonged by about 30 minutes.
Additional Manufacturer Narrative
Batch review performed on 23 feb 2026.Instrument lot 2532556: (b)(4) items manufactured and released on 22 dec 2025.Expiration date: 10 dec 2030.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.Mat 82418:(b)(4) items manufactured and released 23 july 2025.To date, two similar events have been reported on the same lot during the period of review.Clinical evaluation by our clinical affair department.During drilling of the central hole for the baseplate component, the kwire fractured.It was not possible to remove the broken fragment, so the surgeon left it in the patient.Since the evaluation was performed in only one projection, a complete assessment cannot be made from this single view.In any case, it appears reasonable to assume that both the fragments and the kwire remain inside the bone.The instrument is made of surgical grade stainless steel, but it is not approved for long term implantation.Therefore, secondary adverse events cannot be completely excluded.Nevertheless, it is understandable that attempting to retrieve the fragment would have been demanding.Root cause: based on the available information, no definitive root cause can be identified.The device history record review did not reveal any manufacturing-related issues.The breakage is most likely attributable to intraoperative factors (e.G., bone quality, drilling angle, bending/redirection, axial or torsional forces, surgical handling).There is no objective evidence of a manufacturing, material, or design defect.However, the information available is insufficient to conclusively confirm or exclude any specific cause.
Additional Manufacturer Narrative
Batch review performed on 23 feb 2026.Instrument lot 2532556: 75 items manufactured and released on 22 dec 2025.Expiration date: 10 dec 2030.No anomalies found related to the problem.To date, 31 items of the same lot have been sold with no similar reported event during the period of review.Mat 82418: 962 items manufactured and released 23 july 2025.To date, two similar events have been reported on the same lot during the period of review.Conclusions: based on the available information, no definitive root cause can be identified.The device history record review did not reveal any manufacturing-related issues.The breakage is most likely attributable to intraoperative factors (e.G., bone quality, drilling angle, bending/redirection, axial or torsional forces, surgical handling).There is no objective evidence of a manufacturing, material, or design defect.Additionally, r&d performed mechanical tests on both disposable and reusable k-wires.In no cases were we able to replicate the reported breakage; only wire deformation was observed when the wire was intentionally used improperly.Under normal use conditions, no breakage occurred.However, the information available is insufficient to conclusively confirm or exclude any specific cause.Correction/additional information: - d4 - h5 - h8 - batch review and conclusions.

• 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, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 24494908
• Report Number: 3005180920-2026-00169
• Device Sequence Number: 12035069
• Product Code: LXH
• UDI-Device Identifier: 07630971259171
• UDI-Public: 07630971259171
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2026

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: 2532556
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/03/2026
• Supplement Report FDA Received Date: 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2025
• 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: 69 YR
• Patient Sex: Male