MAUDE Adverse Event Report: MEDARTIS AG APTUS; 2.5/2.8 SCREWDRIVER BLADE, HD7, AO

Model Number	A-2013
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Attending was about to use screwdriver when it broke in two pieces.Both pieces were fully retrieved.Charge nurse, attending surgeon, and medartis rep were notified.Charge nurse let attending surgeon know about xray policy.Attending surgeon was okay with reading c-arm results and was confident that no other pieces were left in the patient.What was the original intended procedure?: open reduction internal fixation radius (left).What problem did the user have: device failed (e.G.Broke, couldn't get it to work or stopped working).Therapies being used on the patient at the time of the event that may have caused or contributed to the event.
Additional Manufacturer Narrative
Dhr records confirm that there was no abnormality in device quality that contributed to the event.
Event or Problem Description
During an open reduction internal fixation procedure of the left radius, the attending surgeon was preparing to use a screwdriver when the instrument fractured into two separate pieces.The tip of the blade of the screwdriver broke during the implantation, immediately after the fixation of the trilock 2.8 screw, during the final tightening.This can happen if the torque applied is too high.Both fragments were completely retrieved.The charge nurse, attending surgeon and medartis representative were notified of the incident.The charge nurse advised the attending surgeon regarding the x-ray policy, and the attending surgeon confirmed that, based on the c[-arm images, no additional fragments remained in the patient and further imaging was not required.

• Brand Name: APTUS
• Common Device Name: 2.5/2.8 SCREWDRIVER BLADE, HD7, AO
• Manufacturer (Section D): MEDARTIS AG; hochbergerstrasse 60e; basel, basel city 4057 ; SZ 4057
• MDR Report Key: 23847768
• Report Number: 3003236702-2025-00006
• Device Sequence Number: 21214228
• Product Code: LXH
• UDI-Device Identifier: 07630037872856
• UDI-Public: 07630037872856
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2025

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?: Yes
• Device Model Number: A-2013
• Device Catalogue Number: A-2013
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2025
• Supplement Date Received by Manufacturer: 11/26/2025
• Initial Report FDA Received Date: 12/19/2025
• Supplement Report FDA Received Date: 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Weight: 79 KG
• Patient Ethnicity: Hispanic