MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SHOULDER SYSTEM INSTRUMENT; SHOULDER GENERAL GLENOSPHERE EXTRACTION SCREW

Model Number	04.01.10.0283
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2025.Lot 1957812: (b)(4) items manufactured and released on (b)(6)2020.No anomalies found related to the problem.To date, no similar events have been reported on the same lot during the period of review.Visual inspection: the impossibility to insert freely the screw through the glenosphere suggests that the glenosphere was malpositioned on the baseplate taper.The fact that no glenosphere guide was not used may have resulted in an incorrect alignment of the two implants.The glenosphere screw was then hammered into the glenosphere recess, resulting in the screw getting stuck.This is confirmed by the fact the a high torque applied of the extraction instruments did not lead to the disengagement of the implants.The glenosphere screw shows circular areas where the anodization is removed.This was due to friction with the glenosphere recess and baseplate bore while attempting to tighten the screw.The glenosphere extraction screw appears to be deformed in the picture.The root cause of such a deformation cannot be determined but may be related to the specific surgical application.Additional device involved.Batch review performed on (b)(6) 2025 on reverse shoulder system 04.01.0173.Glenosphere 39xø27 (k170452) lot.2409932.Lot 2409932: (b)(4) items manufactured and released on 05-sept-2024.Expiration date: 2029-aug-21.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.
Event or Problem Description
During the procedure, the screw of the glenosphere could not be inserted properly.After several attempts, the surgeon became frustrated and hammered the screw into the glenosphere but was still unable to tighten it.He then decided to use a new glenosphere and attempted to remove the first one from the baseplate using the dedicated instrument.However, due to the glenosphere being blocked, excessive force was applied, causing the inner part of the glenosphere extraction screw (ref (b)(4)) to bend.A new glenosphere 36xø27 was used, and the surgery was completed with about 30 min delay.Glenosphere guide was not used.

• Brand Name: SHOULDER SYSTEM INSTRUMENT
• Common Device Name: SHOULDER GENERAL GLENOSPHERE EXTRACTION SCREW
• 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: 21595089
• Report Number: 3005180920-2025-00119
• Device Sequence Number: 18362310
• Product Code: LXH
• UDI-Device Identifier: 07630971211896
• UDI-Public: 07630971211896
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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): 03/13/2025

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: 04.01.10.0283
• Device Lot Number: 1957812
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2025
• Initial Report FDA Received Date: 03/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/30/2020
• 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 Sex: Unknown