MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SHOULDER INSTRUMENTS; SHOULDER DISPOSABLE K-WIRE - Ø2.5 INSTRUMENT

Model Number	14.00002
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 22 april 2025 lot 2423167: (b)(4) items manufactured and released on 18-sept-2024.No anomalies found related to the problem.To date, no similar events have been reported on the same lot during the period of review.Considering the mat63104 (b)(4) this is the firts event reported of this type.Clinical evaluation performed by clinical affairs department after surgery it was observed that the k-wire was still in the patient body after the site closure.The incision was promptly reopened and the k-wire was removed.From the radiographic image, we don't know if anything may have been damaged due to the k-wire remained in the patient and subsequently removed.Based on the report, however, we don't believe there was any harm to the patient.
Event or Problem Description
The k-wire was observed in the patient body after the site closure at post-operative image.After the issue was discovered, the incision was promptly reopened and the k-wire was removed.The cause was unknown, but it was possible that it was pushed when drilling for central peg, the surgery was completed successfully.Delay time 1 hour, total surgery time 4 hours.

• Brand Name: SHOULDER INSTRUMENTS
• Common Device Name: SHOULDER DISPOSABLE K-WIRE - Ø2.5 INSTRUMENT
• 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: 22010869
• Report Number: 3005180920-2025-00398
• Device Sequence Number: 5192743
• Product Code: LXH
• UDI-Device Identifier: 07630971259171
• UDI-Public: 07630971259171
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/13/2025

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: 2423167
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2025
• Initial Report FDA Received Date: 05/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/18/2024
• 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: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian