MAUDE Adverse Event Report: MEDICON EG. CHIRURGIEMECHANIKER-GENOSSENSCHAFT MEDICON; RONGEUR

Model Number	57.28.33
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
From staff: while performing part of the patient's spinal surgery, the tip of the instrument being used (spikeless kerrison 3) broke off.No evident harm occurred; the broken piece of the instrument was easily recovered from the patient.

• Brand Name: MEDICON
• Common Device Name: RONGEUR
• Manufacturer (Section D): MEDICON EG. CHIRURGIEMECHANIKER-GENOSSENSCHAFT; 1350 avenue of the americas; 2nd floor; new york NY 10019
• MDR Report Key: 24505657
• Report Number: 24505657
• Device Sequence Number: 13376061
• Product Code: HTX
• UDI-Device Identifier: 04046826404338
• UDI-Public: (01)04046826404338
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/26/2026
• Report Date (Section F): 02/26/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 57.28.33
• Device Catalogue Number: 57.28.33
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/04/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/04/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 23 YR
• Patient Sex: Male
• Patient Weight: 56 KG
• Date Report Sent to FDA: 02/26/2026