MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO; SURGICAL SCREWDRIVER, REUSABLE

Model Number	6067.0055
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip embedded in set screw while trying to remove set screw.The tip was not retrieved and remains in patient.There was nothing placed over the tip to prevent migration.
Additional Manufacturer Narrative
The purpose of this investigation is to evaluate the reported issue of: broken driver tip.Inspection of the instrument could not be completed as the driver was not returned and the tip remains inside the patient.They confirmed that nothing was placed over the driver tip in the locking cap to contain it.There were no images returned to confirm the incent.Supplemental information may be added should the part/more information be returned.The product is within the anticipated risk; therefore, the overall risk of the system has been maintained and will continue to be monitored.

• Brand Name: CREO
• Common Device Name: SURGICAL SCREWDRIVER, REUSABLE
• 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: 24160580
• Report Number: 3004142400-2026-00011
• Device Sequence Number: 15703555
• Product Code: LXH
• UDI-Device Identifier: 00889095167955
• UDI-Public: 00889095167955
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• 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): 01/23/2026

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: 6067.0055
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/30/2025
• Initial Report FDA Received Date: 01/23/2026
• 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
• Patient Age: 67 YR
• Patient Sex: Female