MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. REVOLVE STABILIZATION SYSTEM; 1.6MM NITINOL K-WIRE, 500MM, BLUNT TIP

Model Number	685.007
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being resubmitted for an incident that occurred earlier.The device was not available for evaluation.The imaging provided shows the s2ai screw and the broken k-wire tip.Fracture of the k-wire tip can occur as a result of excessive forces; however, no determinations could be made as to the cause of the reported issue.The following sections have been updated: b4, e1, h2, h6, h10.
Event or Problem Description
It was reported that while placing an s2ai screw through the k-wire, the tip broke off at the distal end and remains in the patient's iliac crest.This event occurred in hong kong.

• Brand Name: REVOLVE STABILIZATION SYSTEM
• Common Device Name: 1.6MM NITINOL K-WIRE, 500MM, BLUNT TIP
• 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: 18837393
• Report Number: 3004142400-2023-00094
• Device Sequence Number: 7246014
• Product Code: LXH
• UDI-Device Identifier: 00849044072105
• UDI-Public: 00849044072105
• 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
• Device Implanted Year: 2023
• 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): 03/02/2024

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: 685.007
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/30/2023
• Initial Report FDA Received Date: 03/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male