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

Model Number	6067.0050
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Inspection of the instrument could not be completed as the driver was not returned, and the tip remains inside the patient.The sales representative 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.Due to timing of the complaint, the sales representative could not be contacted for additional information.Supplemental information may be added should the part/more information be returned.The overall risk of the system has been maintained and there is no further investigation required.
Event or Problem Description
It was reported that extension attempt of previous 3-level construct (6 screws total).The first 4 locking caps were removed at ease with part number 6067.0055.The 5th locking cap posed an issue & ultimately, part number 6067.0055 sheared & broke off, leaving the tip of the shaft to be stuck within the locking cap & tulip.Moving on to the 6th locking cap, the surgeon attempted to use part number 6067.0050 to remove the final set screw.Once more, the tip of the shaft sheared, resulting in the tip being left within the locking cap & tulip.This was a creo threaded system.

• 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: 24499689
• Report Number: 3004142400-2026-00046
• Device Sequence Number: 15981407
• Product Code: LXH
• UDI-Device Identifier: 00889095167948
• UDI-Public: 00889095167948
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 03/03/2026

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: 6067.0050
• Device Lot Number: ADC352JE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/19/2026
• Initial Report FDA Received Date: 03/03/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown