MAUDE Adverse Event Report: MEDARTIS AG APTUS; 3.0 HEADEDCCS LONG THREAD 40/15MM

Catalog Number	A-5886.40/1S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Unintended Radiation Exposure (4565)
Date of Event	06/23/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The following adverse event occured in switzerland (ch).On (b)(6) 2025, the screw (3 mm wide, 40 mm long) was implanted for open reduction and screw osteosynthesis for a displaced fracture of the right ulnar epicondyle.Scheduled removal of the screw was planned for (b)(6) 2025.During professional removal using a suitable instrument, the screw head broke directly at the base of the partially threaded end (transition to the screw head).Despite several attempts to remove the screw completely from the bone using appropriate instruments, small parts of the end of the partial thread (transition to the screw head) broke off.The screw head and the broken fragments were removed and secured.

• Brand Name: APTUS
• Common Device Name: 3.0 HEADEDCCS LONG THREAD 40/15MM
• 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: 24267392
• Report Number: 3003236702-2026-00003
• Device Sequence Number: 18819995
• Product Code: HWC
• UDI-Device Identifier: 07630037868859
• UDI-Public: 07630037868859
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/05/2026

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-5886.40/1S
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2025
• Initial Report FDA Received Date: 02/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female