MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SHOULDER SYSTEM; GLENOID POLYAXIAL LOCKING SCREW - L30

Model Number	04.01.0161
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 13 nov 2025 lot 2515373: (b)(4) items manufactured and released on 06-aug-2025.Expiration date: 2030-jul-17.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.Root cause: although the root cause cannot be confirmed, the screw breakage was most likely due to unintended excessive loading combined with application-specific factors such as hard or sclerotic bone conditions.There is no indication that any device-related issue caused or contributed to the event, and the device history record review did not identify any potential manufacturing-related issues.
Event or Problem Description
The prongs of the glenoid polyaxial locking screw deformed during screw insertion in the superior part of the baseplate using grs glenoid polyaxial screwdriver (ref04.01.10.0646) for screw insertion andmodular screwdriver - t10 tip - small ao(ref04.01.10.0270) for final tightening.The screw had to be cut off.The issue caused 30 min delay (tot time surgery 120 min).Patient & rsquo's bone quality reported to be firm.

• Brand Name: SHOULDER SYSTEM
• Common Device Name: GLENOID POLYAXIAL LOCKING SCREW - L30
• 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: 23655149
• Report Number: 3005180920-2025-01161
• Device Sequence Number: 20039766
• Product Code: PHX
• UDI-Device Identifier: 07630040706483
• UDI-Public: 07630040706483
• 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): 11/26/2025

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: 04.01.0161
• Device Lot Number: 2515373
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2025
• Initial Report FDA Received Date: 11/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2025
• 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: Other
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Race: White