MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SHOULDER SYSTEM; GLENOID POLYAXIAL LOCKING SCREW - L34

Model Number	04.01.0162
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The prongs of the screw broke and the screw could not be removed from the bone.Total surgery time was 3 hours, and the delay time was 20 minutes.The surgeon thinks that the following sequence happened: the first screw was partially inserted, followed by full insertion of the second screw.When an attempt was made to further advance the first screw, it did not move and the screw head fractured.It is presumed that the first screw may have engaged hard cortical bone, and the insertion of the second screw caused the first screw to bend or become misaligned, resulting in it becoming stuck and eventually leading to the screw head failure.Two screws were used for the baseplate, the inferior is the broken one.
Additional Manufacturer Narrative
Batch review performed on 11 june 2025 (b)(4) items manufactured and released on 24/03/2025.Expiration date: 09/03/2030.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.R&d evaluation: the provided picture confirms the breakage of the screw head and the removal of the inner locking screw.The insertion of the second screw prior to fully seating the first one may have led to partial movement of the baseplate that led, together with the high bone quality, to excessive resistance that resulted in breakage of the head screw.No action is suggested.Root cause: although the circumstances cannot be confirmed, the root cause is could be related to the specific conditions of use.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 - L34
• 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: 22380968
• Report Number: 3005180920-2025-00634
• Device Sequence Number: 18500917
• Product Code: PHX
• UDI-Device Identifier: 07630040706490
• UDI-Public: 07630040706490
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K170452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 07/02/2025

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: 04.01.0162
• Device Lot Number: 2503077
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2025
• Initial Report FDA Received Date: 07/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/24/2025
• 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 Age: 81 YR
• Patient Sex: Female
• Patient Weight: 46 KG
• Patient Ethnicity: Non Hispanic