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

Model Number	6067.0050
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The exact cause of the reported issue has not yet been determined.A supplemental report will be submitted following completion of the device evaluation.
Event or Problem Description
It was reported by a representative from (b)(6) that a revision surgery was done to remove a screw and locking cap where the driver tip had broken off and was left inside the patient.
Additional Manufacturer Narrative
Visual inspection found both instrument tips to be fractured.The deformation at the root of the hexalobes is in the clockwise direction, suggesting the incident occurred while loosening.It is possible that the locking cap had excess tissue caught in the threads, causing excessive forces when attempting removal; however, the exact cause of the reported issue could not be determined.The following sections were updated: b4, g6, h2, h6, and h10.
Event or Problem Description
It was reported by a representative from japan that a revision surgery was done to remove a screw and locking cap where the driver tip had broken off and was left inside the patient.

• Brand Name: CREO
• Common Device Name: DRIVER SHAFT, 1/4" QUICK-CONNECT, SHORT
• Manufacturer (Section D): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon 19403
• MDR Report Key: 11323773
• Report Number: 3004142400-2021-00026
• Device Sequence Number: 934752
• Product Code: LXH
• UDI-Device Identifier: 00889095167948
• UDI-Public: 00889095167948
• 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,Followup
• Report Date (Section B): 03/09/2021

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: 6067.0050
• Device Lot Number: ADV052AD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2021
• Initial Date Received by Manufacturer: 01/19/2021
• Supplement Date Received by Manufacturer: 01/19/2021
• Initial Report FDA Received Date: 02/12/2021
• Supplement Report FDA Received Date: 03/11/2021
• 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