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	02/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 7 february 2025 lot 2252714: (b)(4) items manufactured and released on 15-sep-2022.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 during the rsa operation, the drill bit was found broken after the insertion of the inferior polyaxial screw.The drill bit was identified in the subscapular region, near the thoracic wall.It may be possible that during the operation the drill bit perforated the scapula.While surgical-grade stainless steel is used for instruments, it is not approved for long-term implantation.The possibility of fragment migration cannot be entirely excluded and the consequences are thoroughly unpredictable.Given the fragment's location and potential risks, the surgeon must make a thorough evaluation to determine the best course of action for the patient's health.It remains crucial to monitor the patient closely for any potential secondary complications.
Event or Problem Description
The drill bit broke during the drilling of the superior polyaxial screw.Drill guide was used (04.01.10.0274, lot 2159295; 04.01.10.0034, lot 2253841).Immediately the operation was stopped and c-arm device was applied to identify the position of the broken drill's bit at the patient's body.At the radiological exposure, was seen that the remaining part of the broken drill was trapped in the chest, but not to the point of causing any vital problems, according to the opinion of a thoracic surgeon who was called in to assess the situation.The operation was continued and completed successfully (superior and inferior screws placed) and with a very good intraoperative outcome in terms of joint's stability and passive range of motion.The surgery was extended by about 1.5 hours.
Additional Manufacturer Narrative
Visual inspection the drill bit is broken at the base of the cutting section.The shape of the broken section confirms that the failure occurred in torsion, while drilling the glenoid.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: 21547225
• Report Number: 3005180920-2025-00136
• Device Sequence Number: 7856906
• Product Code: LXH
• UDI-Device Identifier: 07630971233805
• UDI-Public: 07630971233805
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2025

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: 2252714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/07/2025
• Supplement Report FDA Received Date: 04/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2022
• 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: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White