MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM GLENOSPHERE 36XØ24.5; REVERSE SHOULDER GLENOSPHERE

Catalog Number	04.01.0169
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was not possible to insert correctly the screws of glenosphere and metaphysis during surgery.The event was likely due to soft tissue interposed between baseplate/glenosphere and missing use of the glenosphere guide.For metaphysis, it was possible that the metaphysis screw was deformed because it was inserted with an angle at first.The surgeon removed bone and soft tissue around the components, take 2 screws from different implants, and completed the surgery successfully.1 hour of delay due to this event.
Additional Manufacturer Narrative
Visual inspection performed by r&d project manager both glenosphere and reverse metaphysis screws have partial removal of the grey color typical of the type-ii anodization.This is commonly due to friction between the screw and outer surfaces (i.E., central bore of the glenosphere and central bore of the reverse metaphysis).The cause of the difficulty in tightening the screws is determined as a malalignment between the glenosphere and the baseplate (likely due to the guide not being used) and between the reverse metaphysis and the humeral diaphysis.No action is suggested.Batch review performed on 29 may 2024 lot 2342015: (b)(4) items manufactured and released on 14-feb-2024.Expiration date: 2029-01-31.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.Batch reviews of the other devices involved in the complaint (performed on 29 may 2024): reverse shoulder system 04.01.0110 humeral reverse metaphysis +0mm/0° (k170452) lot 2345662: (b)(4) items manufactured and released on 20-mar-2024.Expiration date: 2029-03-05.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.Reverse shoulder system 04.01.0151 glenoid baseplate ø24.5x15 (k170452) lot 2335014: (b)(4) items manufactured and released on 20-feb-2024.Expiration date: 2029-02-05.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.Reverse shoulder system 04.01.0184 short humeral diaphysis - cementless - 11 (k180089) lot 2335902: (b)(4) items manufactured and released on 14-nov-2023.Expiration date: 2028-10-24.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.

• Brand Name: REVERSE SHOULDER SYSTEM GLENOSPHERE 36XØ24.5
• Common Device Name: REVERSE SHOULDER GLENOSPHERE
• 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: 19535374
• Report Number: 3005180920-2024-00433
• Device Sequence Number: 8251553
• 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
• Device Implanted Year: 2024
• 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): 06/14/2024

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 Catalogue Number: 04.01.0169
• Device Lot Number: 2342015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2024
• Initial Report FDA Received Date: 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2024
• 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: 81 YR
• Patient Sex: Female
• Patient Weight: 50 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian