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

Model Number	6067.0055
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Neither the device nor any imaging was available for evaluation.Additional information provided that the surgeon used this driver in conjunction with a non-torque limiting handle.It is likely that the driver was subject to excessive force without the use of the torque limiting handle while provisionally tightening the locking cap onto the left l4 pedicle, resulting in the fracture of the instrument tip.It is also likely that the driver fractured due to excessive wear and tear over time; however, the exact cause of the reported issue could not be determined.
Event or Problem Description
It was reported by a representative from the (b)(6) that a creo driver tip broke off in the screw head and remains in the patient.

• Brand Name: CREO
• Common Device Name: DRIVER SHAFT, 1/4" QUICK-CONNECT, LONG
• Manufacturer (Section D): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon 19403
• MDR Report Key: 11417715
• Report Number: 3004142400-2021-00038
• Device Sequence Number: 3412335
• Product Code: LXH
• UDI-Device Identifier: 00889095167955
• UDI-Public: 00889095167955
• Combination Product (Y/N): N
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/02/2021

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: 6067.0055
• Device Lot Number: BTU324ED
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/05/2021
• Initial Report FDA Received Date: 03/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other