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	04/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During the procedure, the drill bit broke, resulting in a significant delay in the procedure (approximately 3 hours over 4 hours and 30 minutes of surgery) due to difficulty in removing the tip piece retrieved and surgery completed successfully.The drill guide was used.The patient`s bone was extremely sclerotic, which led to overheating of the drill bit and required greater force for drilling.
Additional Manufacturer Narrative
Batch review performed on 15 apr 2026 lot 2478373: (b)(4) items manufactured and released on 30-jun-2025.No anomalies found related to the problem.To date, no similar events have been reported on the same lot during the period of review.Clinical evaluation performed by clinical affairs department during the surgical procedure, the drill bit fractured, resulting in a significant delay.The delay was related to the difficulty encountered in removing the broken tip.All broken pieces were successfully retrieved from the patient, and the surgery was ultimately completed successfully.No patient harm was reported as a result of the event.The drill guide was used as intended during the procedure.According to report, the patient`s bone was extremely sclerotic, which required greater force for drilling and led to overheating of the drill bit.The cause of the fracture is therefore presumed to be the excessive force applied due to the highly sclerotic bone condition.Root cause: although not all factors can be confirmed, the specific conditions of use, including the excessive force applied during drilling in extremely sclerotic bone, likely resulted in the collective forces exceeding the inherent limitations of the device.The investigation results do not indicate any potential manufacturing issue or systemic deficiency of the device.

• 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: 25123194
• Report Number: 3005180920-2026-00413
• Device Sequence Number: 16134691
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/08/2026

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: 2478373
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2026
• Initial Report FDA Received Date: 05/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2025
• 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: Unknown