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	02/17/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 24 feb 2026 lot 2531819: (b)(4) items manufactured and released on 18 dec 2025.Expiration date: 2030-dec-01.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 of the device involved in this complaint, (b)(4) items were manufactured and released 23 july 2025.To date, two similar events have been reported on the same semifinished lot during the period of review.Clinical evaluation 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.R&d analysis the k-wire appears to be approximately 4-5 cm shorter than its original length due to the fracture that occurred.The broken end is bent out of alignment with the axis of the instrument.In addition, it is clearly visible that the segment at the fracture point has undergone torsion and crushing.At the broken end, the piece also shows a notched surface with small circular marks, likely related to the use of the central peg reamer, which marked the outer surface during use.There is also a polished surface, presumably also caused by contact with the central peg reamer during use.In order to better analyse what happened, a functional test has been carried out to replicate what likely occurred during the surgical procedure; however, it was possible to reproduce a similar effect for the first described surface, but not for the second.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.
Event or Problem Description
After drilling the central peg hole for the baseplate, the k-wire fractured.The fragment became lodged in the patient`s bone and could not be retrieved.

• 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: 24625499
• Report Number: 3005180920-2026-00202
• Device Sequence Number: 8688718
• 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): 03/18/2026

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: 2531819
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2026
• Initial Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/18/2025
• 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: 77 YR
• Patient Sex: Unknown
• Patient Race: White