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

Model Number	6120.5000
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/19/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was n:morted that the tio of the threaded lockinq cap driver broke off within the set screw and could not be retrieved.
Additional Manufacturer Narrative
This report is being resubmitted for an incident that occurred earlier.Visual inspection of the driver found the tip to be twisted and fractured.The fracture surface extends across the drive teature along the edge of the retaining feature , indicating that the driver was fully seated into the locking cap.The observed damage is consistent with over-torqueing the.Locking cap above the recommended torque limit.However, the exact cause of the reported issue could not be determined.The following sections have been updated: b4, e1, e3, g7, h2, h3, 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: 18839366
• Report Number: 3004142400-2020-00053
• Device Sequence Number: 7132486
• 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): 03/05/2024

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: VIV052BB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/21/2020
• Initial Report FDA Received Date: 03/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2018
• 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: 54 YR
• Patient Sex: Male
• Patient Weight: 122 KG
• Patient Race: Asian