MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SHOULDER SYSTEM; REVERSE SHOULDER SYSTEM 04.01.0210 LAT. GLENOSPHERE 36XØ27

Model Number	04.01.0210
Medical Device Problem Code	Damaged Thread (4075)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 11-06-2025 lot 2400597: (b)(4) items manufactured and released on 08-04-2024 expiration date: 2029-03-24.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.Visual inspection performed by r&d manager: the glenosphere presented only minor marks and signs on its taper connection with the baseplate, probably due to the fact - as detailed in the event description - that the glenosphere and the baseplate mated correctly.The chamfer at the end of the glenosphere pass-thorough hole presented minor signs of wear and some dents.During visual inspection, the subject device was coupled correctly and without issues with a threaded baseplate ø27.The two available glenosphere screws from the complaint were free to move in the glenosphere hole, both in translation and rotation.The glenosphere screws presented both major scratches and usage marks: the head and the cylindrical portion were discolored.The threaded portion was heavily damaged in both screws, particularly in the first 4 threads, that were completely smoothened out.From the marks on the screws, a possible root case can be traceable on a misalignement of the glenosphere and/or screw insertion, possibly at the level of the glenosphere chamfer.The damage on the thread lead to the difficulty of screwing in the following trials.Other devices involved: reverse shoulder system 04.01.0177 glenosphere screw (k170452) lot 2341007: (b)(4) items manufactured and released on 08-11-2023 expiration date: 2028-10-23.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.The issue reported may have been caused by a misalignment between the glenosphere and the screw during insertion that led to the damage of the screw thread preventing subsequent insertion attempts but based on the information available no definitive root cause can be established while the device history record review does not indicate any potential manufacturing related issue.
Event or Problem Description
During tsa the while the glensphere seemed correctly seated the glenosphere screw got stuck during insertion and could not be screwed in, even using the dedicated glenosphere guide.The surgeon also trimmed the bone around the baseplate and attempted to insert the screw again to no avail.A new screw was opened but also the second screw could not be seated.The surgeon then decided to change the glenosphere with a new one, not having one of the same ref implanted a std.Glenosphere 39xø27 (ref.04.01.0173).45 minutes of delay over a 4.5 hours surgery were reported.

• Brand Name: SHOULDER SYSTEM
• Common Device Name: REVERSE SHOULDER SYSTEM 04.01.0210 LAT. GLENOSPHERE 36XØ27
• 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: 22467162
• Report Number: 3005180920-2025-00626
• Device Sequence Number: 4096805
• Product Code: HSD
• UDI-Device Identifier: 07630040728096
• UDI-Public: 07630040728096
• 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): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/10/2025

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: 04.01.0210
• Device Lot Number: 2400597
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2025
• Initial Report FDA Received Date: 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2024
• 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: 72 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian