MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO; DRIVER SHAFT, 1/4" QUICK-CONNECT, SHORT

Model Number	6067.0050
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being resubmitted for an incident that occurred earlier.The driver was returned for evaluation with the tip having fractured during final tightening.The broken tip was not returned as it remains in the patient.It was stated that the driver may not have been fully seated in the locking cap, which may have contributed lo the reported issue.No determination can be made as to the exact cause of the fracture.The following sections have been updated: b4, e1, e3, h2, h6, h10.
Event or Problem Description
The tip of the screwdriver fractured on the final torque of the set screw.The driver may not have been fully seated in the locking cap.

• Brand Name: CREO
• Common Device Name: DRIVER SHAFT, 1/4" QUICK-CONNECT, SHORT
• 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: 18825369
• Report Number: 3004142400-2018-00024
• Device Sequence Number: 18089140
• Product Code: LXH
• UDI-Device Identifier: 00889095167948
• UDI-Public: 00889095167948
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/01/2024

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: ADT342AC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/20/2018
• Initial Report FDA Received Date: 03/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 68 YR
• Patient Sex: Female
• Patient Weight: 88 KG
• Patient Race: White