MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CITADEL¿; SET SCREW POSITIONER, TORQUE LIMITING, 1.5NM

Model Number	630.503
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The instrument was not returned for evaluation, therefore the resources used for the analysis were limited to images of the broken tip and description provided.Per the description, the set screw positioner functioned as intended when tightening the set screw, torqueing out clockwise at 1.5nm with an audible click.However, when the surgeon then attempted to rotate the screw back counterclockwise, the tip broke off.This is possibly due to the handle being designed to limit torque only in the clockwise direction.Torque in the ccw direction would not be limited and if the surgeon rotated with excessive force it is possible the force could be enough to cause the tip to snap off.Additionally, if the diver tip was not fully seated in the screw hole this could have contributed as well.While these factors may have contributed to the reported issue, an exact cause cannot be determined.The complaint is deemed indeterminate.If the part is returned in the future the investigation will be updated.The observed risk level is low, which is within the expected risk.
Event or Problem Description
It was reported that when the surgeon final tightened the fuchsia truss¿ clamping set screw, he inserted the set screw positioner, torque limiting, 1.5nm into the set screw, making sure the hex was fully seated in the screw head, and turned the set screw positioner clockwise to the click.Then he decided to open the set screw again to make some more compression in the truss plate and when he turned the set screw positioner counterclockwise the tip of the instrument broke off, staying blocked into the set screw head without possibility to remove it.The surgeon therefore had to finish the surgery with the tip of the instrument into the set screw and consequently into the patient.

• Brand Name: CITADEL¿
• Common Device Name: SET SCREW POSITIONER, TORQUE LIMITING, 1.5NM
• Manufacturer (Section D): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon PA 19403
• Manufacturer (Section G): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon PA 19403
• Manufacturer Contact: daniel paul ; 2560 general armistead avenue; audubon, PA 19403 ; 6109301800
• MDR Report Key: 23360983
• Report Number: 3004142400-2025-00238
• Device Sequence Number: 12965608
• Product Code: LXH
• UDI-Device Identifier: 00849044085198
• UDI-Public: 00849044085198
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: D154976
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/22/2025

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: 630.503
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/23/2025
• Initial Report FDA Received Date: 10/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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