MAUDE Adverse Event Report: MEDARTIS AG APTUS; 2.8 TRILOCK DIST.HUM.PL POST.LAT. 15H, R

Model Number	A-4856
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/27/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The plate complied with all quality requirements (dhr) at the time of release.Based on the provided details, the reported postoperative breakage cannot be linked to a manufacturing issue.Since the beginning of 2018, not a single complaint has been submitted regarding article a-4856.54.Postoperative x-ray images were provided.A conclusive root cause could not be established and further actions were not initiated.
Event or Problem Description
This event occurred in (b)(6).The patient sustained a fracture of the posterolateral aspect of the distal humerus at the proximal end, specifically at the compression foramen.The surgeon removed the two previously implanted plates[?]the medial and posterolateral[?]and replaced them with new implants.In addition, two intramedullary screws were inserted to provide supplementary support.Date of first surgery: (b)(6) 2026, date of second surgery: (b)(6) 2026.

• Brand Name: APTUS
• Common Device Name: 2.8 TRILOCK DIST.HUM.PL POST.LAT. 15H, R
• Manufacturer (Section D): MEDARTIS AG; hochbergerstrasse 60e; basel, basel city 4057 ; SZ 4057
• Manufacturer Contact: lidija krebs ; hochbergerstrasse 60e; basel, basel city 4057 ; SZ 4057
• MDR Report Key: 25426291
• Report Number: 3003236702-2026-00010
• Device Sequence Number: 5988737
• Product Code: HRS
• UDI-Device Identifier: 07630008440282
• UDI-Public: 07630008440282
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K112560
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/08/2026

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?: No
• Device Model Number: A-4856
• Device Catalogue Number: A-4856.54
• Device Lot Number: 25454443
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2026
• Initial Report FDA Received Date: 06/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Required Intervention; Hospitalization
• Patient Sex: Unknown