MAUDE Adverse Event Report: MEDARTIS AG APTUS; 2.5 TRILOCK SCREW 14MM, HD7

Catalog Number	A-5750.14/1S
Medical Device Problem Codes	Break (1069); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Insufficient Information (4580)
Date of Event	03/03/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A follow-up will be sent if new information is retrieved.
Event or Problem Description
At (b)(6) hospital in (b)(6), a surgeon performing wrist surgery utilized a 2.5 trilock ulna shortening plate in combination with a 2.5 trilock screw.During insertion of the 2.5 trilock screw into the second distal hole of the plate and subsequent locking with a driver, the screw head separated.The broken screw remained in situ, and this incident will be reported to the pmda.Intraoperatively, the surgeon assessed that removal of the broken screw during the same procedure would be challenging.Consequently, the decision was made to leave the fragment in place, with plans to employ a rescue kit or a comparable solution for extraction at the time of screw removal.The surgeon reported that the patient's bone quality was hard.The screw was pre-drilled with a suitable twist drill, and based on the available information, excessive force was not applied during insertion.No additional x-rays are available for analysis.Despite this intraoperative complication, the surgeon confirmed that the intended surgical outcome was achieved.

• Brand Name: APTUS
• Common Device Name: 2.5 TRILOCK SCREW 14MM, HD7
• 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: 24757002
• Report Number: 3003236702-2026-00007
• Device Sequence Number: 9376931
• Product Code: HWC
• UDI-Device Identifier: 07630037882060
• UDI-Public: 07630037882060
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: A-5750.14/1S
• Device Lot Number: 25449782
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/01/2026
• Supplement Report FDA Received Date: 06/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Unknown