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

Model Number	685.008
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/30/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being resubmitted for an incident that occurred earlier.Neither the device or any imaging could be provided for evaluation.The type of damaged observed may have been caused from a deviation of trajectory that would cause an interference between the k-wire and instrument/implant.That interference could then place excessive force on the tip of the k-wire during removal and cause it to fracture.However, no determinations could be made as to the cause of the reported issue.
Event or Problem Description
It was reported that the tip of a k-wire broke off at the distal end and remains in the patient's body.

• Brand Name: REVOLVE STABILIZATION SYSTEM
• Common Device Name: 1.6MM NITINOL K-WIRE, 500MM, SHARP 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: 18834178
• Report Number: 3004142400-2023-00060
• Device Sequence Number: 12574205
• Product Code: LXH
• UDI-Device Identifier: 00849044072112
• UDI-Public: 00849044072112
• 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): 03/01/2024

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: 685.008
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/30/2023
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 74 YR
• Patient Sex: Female