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	02/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review could not be performed as the lot number of the device involved in the event is unknown.Clinical evaluation performed by medical affairs department during rsa, a fragment of the drill bit fractured remained attached in the glenoid.The material of the instruments is surgical grade stainless steel, however 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 judgement in the interest of the patient's health.Based on the information available no definitive root cause can be established, although it is likely that excessive force applied during its use contributed to the event.
Event or Problem Description
The drill bit for glenoid polyaxial screws broke and remained in the glenoid.The surgeon inserted the screw in a different direction than the drill.5 min delay.

• 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: 21685764
• Report Number: 3005180920-2025-00199
• Device Sequence Number: 8730783
• 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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2025
• Initial Report FDA Received Date: 03/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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