MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CAPTIVATE; TB DRIVER, CANNULATED, 80MM, AO QUICK-CONNECT

Model Number	6188.6306
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/31/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being resubmitted for an incident that occurred earlier.Evaluation of the returned device found the tip of the driver to be broken at approximately 45 degrees, representative of a torsional failure.It's possible the observed damage was caused by excessive force or torque on the driver tip in very hard bone.Additionally, using the driver without prepping the space with the provided instrumentation prior to insertion could have contributed.However, the exact cause of the reported issue cannot be determined.
Event or Problem Description
It was reported that the driver tip sheared off leaving a fragment lodged in the screw socket.The surgeon did not remove the fragment and it remains in the patient.

• Brand Name: CAPTIVATE
• Common Device Name: TB DRIVER, CANNULATED, 80MM, AO 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: 18828308
• Report Number: 3004142400-2019-00016
• Device Sequence Number: 7786614
• Product Code: LXH
• UDI-Device Identifier: 00889095732009
• UDI-Public: 00889095732009
• 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: 6188.6306
• Device Lot Number: ADV115BC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/01/2019
• Initial Report FDA Received Date: 03/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2018
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Race: White