MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SHOULDER SYSTEM INSTRUMENT; GLENOID POLYAXIAL SCREWDRIVER - NON-RETENTIVE

Model Number	04.01.10.0284
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 18 may 2026, lot 2155524: (b)(4) items manufactured and released on 29-nov-2021.No anomalies found related to the problem.To date, no similar events have been reported on the same lot during the period of review.
Event or Problem Description
After the surgery (wound closure), the x-rays examination revealed that the tip of the instrument had broken.The wound was reopened, and the broken fragment was removed.No fragments remain inside the body.The surgery was completed successfully.The total surgery time was 3.5 hours, and the delay time was 1.5 hours.

• Brand Name: SHOULDER SYSTEM INSTRUMENT
• Common Device Name: GLENOID POLYAXIAL SCREWDRIVER - NON-RETENTIVE
• 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: 25313935
• Report Number: 3005180920-2026-00504
• Device Sequence Number: 10511857
• Product Code: LXH
• UDI-Device Identifier: 07630971211902
• UDI-Public: 07630971211902
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2026

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: 04.01.10.0284
• Device Lot Number: 2155524
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/28/2026
• Supplement Report FDA Received Date: 07/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/29/2021
• 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: Required Intervention
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian