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

Model Number	6067.0060
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the distal tip sheared off in locking cap due to torque not releasing.The tip was left in the patient.
Additional Manufacturer Narrative
An investigation of the reported failure could not be completed as the parts were not returned.The sales rep was contacted regarding this event to confirm details regarding the device failure.He confirmed that there was no impact on patient health.After the driver tip broke off, it was unable to be removed from the locking cap in the l4 screw, the surgeon completed the case successfully using rod-rod connectors.The product is within the anticipated risk; therefore, the overall risk of the system has been maintained and will continue to be monitored.No determinations could be made as to the cause of the reported issue.

• 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: 25082103
• Report Number: 3004142400-2026-00094
• Device Sequence Number: 16085178
• Product Code: LXH
• UDI-Device Identifier: 00889095167979
• UDI-Public: 00889095167979
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 05/05/2026

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: 6067.0060
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/10/2026
• Initial Report FDA Received Date: 05/05/2026
• 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 Age: 75 YR
• Patient Sex: Female
• Patient Weight: 62 KG
• Patient Race: White