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

Model Number	6067.0060
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Spinal Column Injury (2081)
Date of Event	02/26/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when backing out the screw at l4, the driver tip broke off within the screw head.The tip was not able to be retrieved.
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 that the driver fractured due to excessive torque or insufficient engagement with the mating screw.The location and angle of the fracture surface indicates that the driver may not have been fully engaged or angled at the time of breakage.However, the exact cause of the reported issue cannot be determined.

• Brand Name: CREO
• Common Device Name: SELF-RETAINING DRIVER SHAFT, 1/4" QUICK-CONNECT
• 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: 18829843
• Report Number: 3004142400-2019-00020
• Device Sequence Number: 12709183
• Product Code: LXH
• UDI-Device Identifier: 00889095167979
• UDI-Public: 00889095167979
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/04/2024

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
• Device Model Number: 6067.0060
• Device Lot Number: VIT312AE
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/27/2019
• Initial Report FDA Received Date: 03/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2016
• 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 Age: 69 YR
• Patient Sex: Male
• Patient Race: White