MAUDE Adverse Event Report: Medacta International SA Shoulder Instruments; Shoulder disposable k-wire - Ø2.5

Model Number	14,00002
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2026
Type of Reportable Event	Malfunction

• Brand Name: Shoulder Instruments
• Common Device Name: Shoulder disposable k-wire - Ø2.5
• 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: 50125771
• Report Number: 3005180920-2026-00799
• Device Sequence Number: 18770099
• Product Code: LXH
• UDI-Device Identifier: 07630971259171
• UDI-Public: 07630971259171
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2026

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: 2614691
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/04/2026
• Supplement Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2026
• 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: 65 YR
• Patient Sex: Female
• Patient Race: White