MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO; THREADED LOCKING CAP DRIVER

Model Number	6120.5000
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/19/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the surgeon used the correct locking cap driver to implant the creo amp threaded end cap.He passed it through the counter torque, into the 20mm reduction tulips, and began tightening the end cap into the construct.Upon removing the driver from the initial tightening he noticed the tip of the screwdriver had broken off in the end cap.Surgeon attempted to remove the broken piece, however it sat flush inside the end cap.No adhesive or instrument was able to remove it and the broken screwdriver tip was left within the end cap.
Additional Manufacturer Narrative
This report is being resubmitted for an incident that occurred earlier.The instrument was returned for evaluation and it was confirmed that the driver tip had sheared off.It is possible the driver may have experiencedexcessive forces or torque during implantation.However, the exact cause of the reported issue cannot be determined.The following sections have been updated for this supplemental report: b4, e1, g6, h2, h6, h10.

• Brand Name: CREO
• Common Device Name: THREADED LOCKING CAP DRIVER
• 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: 18809726
• Report Number: 3004142400-2019-00050
• Device Sequence Number: 12574794
• Product Code: LXH
• UDI-Device Identifier: 00889095173604
• UDI-Public: 00889095173604
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K124058
• 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): 02/28/2024

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: 6120.5000
• Device Lot Number: VIT126CB
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/25/2019
• Initial Report FDA Received Date: 02/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2016
• 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