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

Model Number	6120.5000
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being resubmitted for an incident that occurred earlier.The instrument is unavailable for evaluation.The broken tip is not secured via any mechanical thread or feature which would prohibit it from becoming separated from the locking cap.Creo locking cap driver tip is made from 400 series stainless steel commonly used in surgical tools and instruments.No determination could be made as to the cause of the breakage.
Event or Problem Description
The tip of a threaded locking cap driver broke off in the locking cap during surgery.The surgeon was unable to remove the broken tip and it remains in the patient.

• 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: 18825399
• Report Number: 3004142400-2018-00026
• Device Sequence Number: 2970354
• 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): 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 6120.5000
• Device Lot Number: VIU115BB
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2017
• 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: 62 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian