MAUDE Adverse Event Report: MEDARTIS AG APTUS; SCREW, FIXATION, BONE

Model Number	A-5750.18/1
Medical Device Problem Codes	Break (1069); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A follow-up will be sent if new information is retrieved.
Event or Problem Description
One 18 mm screw broke off into the left radius during surgical procedure.Head of screw retrieved and placed on sterile field; however, the surgeon determined that it would cause more damage to try to drill out the rest of the screw shaft and it was left in the radius.No harm to patient.The head of the screw was retrieved.
Event or Problem Description
One 18mm screw broke off into the left radius during surgical procedure.Head of screw retrieved and placed on sterile field, however the surgeon determined that it would cause more damage to try to drill out the rest of the screw shaft and it was left in the radius.No harm to patient.The head of the screw was retrieved.
Additional Manufacturer Narrative
The investigation show that the screw broke in the screw shaft (pictures were provided in advance).Screws can break due to increased insertion torque.Increased insertion torque can be caused by hard bone or not adequate pre drilling (e.G.Wrong drilling size / wrong drilling depth).Investigation of the screw`s manufacturing record (dhr) without the lot number it's not possible.A more detailed investigation of the adverse event could not be carried out because neither x-ray images nor details of the treatment were provided.A follow-up will be sent if new information is retrieved.

• Brand Name: APTUS
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): MEDARTIS AG; hochbergerstrasse 60e; basel, basel city 4057 ; SZ 4057
• Manufacturer Contact: lidija krebs ; hochbergerstrasse 60e; basel, 4057 ; SZ 4057
• MDR Report Key: 23266831
• Report Number: 3003236702-2025-00003
• Device Sequence Number: 13300595
• Product Code: HWC
• UDI-Device Identifier: 07630008405427
• UDI-Public: 07630008405427
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: A-5750.18/1
• Device Catalogue Number: A-5750.18/1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2025
• Supplement Date Received by Manufacturer: 09/11/2025
• Initial Report FDA Received Date: 10/10/2025
• Supplement Report FDA Received Date: 11/26/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male