MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SHOULDER SYSTEM; GLENOID POLYAXIAL LOCKING SCREW - L22

Model Number	04.01.0159
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Intraoperatively, the surgeon initially judged that the head had merely been stripped.However, a postoperative x-ray revealed that the broken screw head had migrated and entered the humerus.On the same day, additional surgical intervention was performed tore move the screw fragment through an incision.The cause is unknown, but it is possible that the screw head broke during the final tightening phase.The surgery was completed successfully.The total surgery time was 2 hours, and the delay time was 1 hour.The screw involved was located in the superior part of the baseplate.A total of four polyaxial screws, including the broken one, were placed.
Additional Manufacturer Narrative
Batch review performed on 31 oct 2025 lot 2512947: (b)(4) items manufactured and released on 07/jul/2025.Expiration date: 16/jun/2030.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Investigation performed by r& d project manager.The internal screw of the glenoid polyaxial locking screw 04.01.0159 broke during surgery.The screwdriver used for the whole insertion of the screw was ref.04.01.10.0284, which is intended to be used only for the final tightening, instead of the 04.01.10.0281 polyaxial screwdriver modular tip.This may have lead to eccessive stresses on the glenoid polyaxial screw head.Root cause: the root cause is likely related to the specific conditions of use, involving an unintended instrument combination.There is no indication of a systemic deficiency or potential manufacturing related root cause.

• Brand Name: SHOULDER SYSTEM
• Common Device Name: GLENOID POLYAXIAL LOCKING SCREW - L22
• 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: 23583100
• Report Number: 3005180920-2025-01131
• Device Sequence Number: 21227104
• Product Code: PHX
• UDI-Device Identifier: 07630040706469
• UDI-Public: 07630040706469
• Combination Product (Y/N): N
• PMA/510(K) Number: K170452
• 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): 11/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 04.01.0159
• Device Lot Number: 2512947
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2025
• Initial Report FDA Received Date: 11/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2025
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian