MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SHOULDER SYSTEM INSTRUMENT; SHOULDER GENERAL 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	03/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The drill bit for glenoid polyaxial screws broke and remained in the glenoid.The surgeon inserted a smaller screw to avoid interference with the polyaxial screw.Young patient, bone was not sclerotic; 5 minutes delay.
Additional Manufacturer Narrative
Clinical evaluation during the primary rsa, a small fragment of the drill bit for glenoid polyaxial screws fractured remained in the bone.The surgeon inserted a smaller screw to avoid interference with the broken drill bit.The material of the instruments is surgical-grade stainless steel, however, it is not approved for long-term implantation.Occasionally, fragments of broken instruments may be left in the body and the insurgence of adverse reactions is extremely rare.However, in this specific case, the possibility of fragment migration may exist and therefore, the surgeon must make the best judgment in the interest of the patient's health.Batch review performed on 6 march 2025 lot 2052539: (b)(4) items manufactured and released on 07-aug-2020.No anomalies found related to the problem.To date, one similar event has been reported on the same lot during the period of review.The investigation results do not indicate any potential manufacturing issue.The specific conditions of application may have influenced the issue, but this cannot be confirmed.

• Brand Name: SHOULDER SYSTEM INSTRUMENT
• Common Device Name: SHOULDER GENERAL DRILL BIT FOR GLENOID POLYAXIAL SCREWS
• 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: 21687571
• Report Number: 3005180920-2025-00218
• Device Sequence Number: 9420163
• Product Code: LXH
• UDI-Device Identifier: 07630971233805
• UDI-Public: 07630971233805
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 03/25/2025

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: 04.01.10.0050
• Device Lot Number: 2052539
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2025
• Initial Report FDA Received Date: 03/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/07/2020
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown