MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SHOULDER SYSTEM; REVERSE SHOULDER SYSTEM 04.01.0169 GLENOSPHERE - Ø36X24.5

Model Number	04.01.0169
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
When connection the glenosphere to the baseplate, it did not fully seat.The glenosphere screw locked approximately 2-3 mm before fully engaging in the baseplate.The glenosphere was reinserted after cleaning around the baseplate, but the situation did not change.When rechecking the screw head, the tip of the screw showed silver wear marks.So, the screw alone was inserted.Then, a grinding noise was heard, so it was replaced with a new screw (ref.04.01.0177, lot: 2418605).The glenosphere guide (ref 04.01.10.0432) was used.The surgery was completed successfully.There were 30 minutes delay to insert the screw into the baseplate (tot time 2.5 hours).
Additional Manufacturer Narrative
Batch review performed on 28 may 2025.Lot: 2434142: (b)(4) items manufactured and released on 31-mar-2025.Expiration date: 2030-03-18.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.Other devices involved: reverse shoulder system 04.01.0151 glenoid baseplate - ø24.5x15 lot: 2429981 (k170452): (b)(4) items manufactured and released on 21-feb-2025.Expiration date: 2030-02-05.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.Based on the information available no definitive root cause can be established, while the device history record review does not indicate any potential manufacturing-related issue or systemic deficiency.Although it cannot be confirmed, the issues reported may have been caused by a suboptimal alignment between the glenosphere and the baseplate.

• Brand Name: SHOULDER SYSTEM
• Common Device Name: REVERSE SHOULDER SYSTEM 04.01.0169 GLENOSPHERE - Ø36X24.5
• 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: 22326365
• Report Number: 3005180920-2025-00563
• Device Sequence Number: 8812543
• Product Code: PHX
• UDI-Device Identifier: 07630040706568
• UDI-Public: 07630040706568
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/25/2025

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: 04.01.0169
• Device Lot Number: 2434142
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2025
• Initial Report FDA Received Date: 06/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/27/2025
• 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: 77 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian