MAUDE Adverse Event Report: GETSET SURGICAL S.A. GOPLF! CORE SET; T-HANDLE SCREWDRIVER

Model Number	4010001
Medical Device Problem Codes	Break (1069); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
From the information provided by the surgeon a patient was admitted for a planned surgery to fixate the adjacent level to a construct of getset surgical's implants inserted 1.5 years prior (fusion was achieved l5/s1).The surgeon intended to extend the construct by removing the current rod.This required removal of the set-screw.The break away tip on the t25 driver broke during the removal of the set-screw.The tip of the driver broke cleanly and the entirety of the tip was successfully retrieved with < 5 minute delay in surgery.
Additional Manufacturer Narrative
Mdr reporting as a result of fda inspectional observation to submit and mdr report in the usa.

• Brand Name: GOPLF! CORE SET
• Common Device Name: T-HANDLE SCREWDRIVER
• Manufacturer (Section D): GETSET SURGICAL S.A.; route de la corniche 4; epalinges vaud, 1066 ; SZ 1066
• Manufacturer (Section G): IN'TECH ASIA PACIFIC; 2821, tingkat perusahaan 5a; prai industrial estate 13600; penang, malaysia ; MY
• Manufacturer Contact: jowiita sokalska ; route de la corniche 4; epalinges vaud, 1066 ; SZ 1066
• MDR Report Key: 23561239
• Report Number: 3017780544-2025-00002
• Device Sequence Number: 10148928
• Product Code: NKB
• UDI-Device Identifier: 07640387660829
• UDI-Public: 07640387660829
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K202505
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/14/2025

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 Expiration Date: 08/09/2026
• Device Model Number: 4010001
• Device Catalogue Number: 4010001
• Device Lot Number: SMG222116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/25/2025
• Initial Report FDA Received Date: 11/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/14/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown