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

Model Number	6067.0055
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Spinal Column Injury (2081)
Date of Event	07/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being resubmitted for an incident that occurred earlier.The device was available for evaluation.It was reported that the distal tip of the instrument fractured and the broken piece was left in the screw head.Visual inspection of the instrument confirmed the hexalobular tip sheared off from the driver shaft with signs of torsional deformation consistent with clockwise rotation of the instrument during final tightening.Dimensional and functional analysis could not be completed due to the fracture.The fracture of the tip may have been caused by high forces experienced during tightening.However, because the surgical conditions cannot be replicated, no determinations could be made as to the cause of the reported issue.The following sections have been updated: b4; d4; d8; e1; h2; h3; h6; h10.
Event or Problem Description
It was reported that during surgery the tip of the driver shaft broke off and was left in the set screw.

• Brand Name: CREO
• Common Device Name: DRIVER SHAFT, 1/4 INCH QUICK-CONNECT, LONG
• 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: 18837894
• Report Number: 3004142400-2023-00117
• Device Sequence Number: 20644445
• Product Code: LXH
• UDI-Device Identifier: 00889095167955
• UDI-Public: 00889095167955
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: D154976
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 02/27/2024

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: 6067.0055
• Device Lot Number: BTU133GC
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/19/2023
• Initial Report FDA Received Date: 03/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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