MAUDE Adverse Event Report: Medacta International SA Shoulder System Instrument; Drill bit for glenoid polyaxial screws

Model Number	04.01.10.0050
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2026
Type of Reportable Event	Malfunction

• Brand Name: Shoulder System Instrument
• Common Device Name: Drill bit for glenoid polyaxial screws
• 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: 50543248
• Report Number: 3005180920-2026-00849
• Device Sequence Number: 13408906
• Product Code: LXH
• UDI-Device Identifier: 07630971233805
• UDI-Public: 07630971233805
• 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
• Type of Report: Initial
• Report Date (Section B): 09/01/2026

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: 04.01.10.0050
• Device Lot Number: 2474160
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/26/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2026
• Initial Report FDA Received Date: 09/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female