MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SPINE INSTRUMENTS; TAP Ø4.5 AGGRESSIVE REINFORCED UNDERSIZED

Model Number	03.51.10.8500
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The tip of the d 4.5 aggressive reinforced undersized tap fractured during use in highly sclerotic bone.The broken fragment was successfully located and removed, and the surgery was completed successfully without any reported patient harm.40-minute delay (180 min total surgery time).
Additional Manufacturer Narrative
Batch review performed on 22 may 2026 lot 2263917: (b)(4) items manufactured and released on 03-apr-2023.No anomalies found related to the problem.To date, no similar events have been reported on the same lot.Analysis performed by r&d manager: tip fracture likely occurred due to elevated torsional loads during tapping in highly sclerotic bone.Root cause: the reported issue may have occurred due to high torsional loading resulting from the combined factors of screw diameter, bone condition, and the specific conditions of the screw hole preparation, in combination with the inherent mechanical limits of the devices involved.The device history record review does not indicate any potentially related manufacturing issue.

• Brand Name: SPINE INSTRUMENTS
• Common Device Name: TAP Ø4.5 AGGRESSIVE REINFORCED UNDERSIZED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro 6874 ; SZ 6874
• MDR Report Key: 25528752
• Report Number: 3005180920-2026-00571
• Device Sequence Number: 13197597
• Product Code: LXH
• UDI-Device Identifier: 07630345702272
• UDI-Public: 07630345702272
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/17/2026

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 Expiration Date: 04/03/2023
• Device Model Number: 03.51.10.8500
• Device Lot Number: 2263917
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2026
• Initial Report FDA Received Date: 06/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/03/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown