MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SHOULDER SYSTEM; REVERSE SHOULDER SYSTEM LAT. GLENOSPHERE 39XØ27

Model Number	04.01.0211
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/12/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 12 december 2024: lot 2414222: 24 items manufactured and released on 28-oct-2024.Expiration date: 2029-oct-14.No anomalies found related to the problem.To date, 3 items of the same lot have been sold with no similar reported event during the period of review.Batch review performed on 12 december 2024: reverse shoulder system 64.01.9009 sf glenosphere screw (k193175) lot 2417282: 500 items manufactured and released on 30-sep-2024.Expiration date: 2029-oct-14.No anomalies found related to the problem.
Event or Problem Description
The glenosphere screw could not be fully inserted and tightened.The baseplate (ref.(b)(4) ) and polyaxial screws were removed and reinserted, but the glenosphere screw did not lock.Another glenosphere (ref.(b)(4) ) was used.The surgery was completed successfully.Total surgery time was 1 hour and 36 minutes, the delay time was 20 minutes.The 20 minutes delay occurred because the polyaxial screws and glenosphere were removed and new ones used, and also the baseplate was removed and reinstalled (polyaxial screws changed).
Additional Manufacturer Narrative
Visual inspection: the glenosphere did not present any sign of wear or damage, not in the central hole and thread, nor in the backsurface in contact with the glenoid baseplate.The glenosphere screw presented major signs of wear on the ehad side, on its cylinrical portion and on the thread as well.The first three threads are blunt.The torx connection did not show any sign of wear or damage.From the visual analysis it is not possible to identify a root cause of the complaint.Although it is not possible to define a root cause, there is no indication that any potential issue with the device may have caused or contributed to the event, and the device history record review does not indicate any potential manufacturing related issue.

• Brand Name: SHOULDER SYSTEM
• Common Device Name: REVERSE SHOULDER SYSTEM LAT. GLENOSPHERE 39XØ27
• 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: 21111329
• Report Number: 3005180920-2024-01136
• Device Sequence Number: 18313368
• Product Code: HSD
• UDI-Device Identifier: 07630040728102
• UDI-Public: 07630040728102
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K193175
• 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): 02/20/2025

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: 04.01.0211
• Device Lot Number: 2414222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/09/2025
• Supplement Report FDA Received Date: 02/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/28/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian