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

Model Number	685.007
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Neither the device or any imaging could be provided for evaluation.Additional information provided that the direction of the tap was deviated from the direction of the k-wire.The trajectory of the k-wire was not correct and the surgeon tried to correct this with the tap over the k-wire.As the k-wire is meant to be the guide, this trajectory should not be deviated from while inserting instruments over it.However, the exact trajectory and "deviation" cannot be qualified/quantified, no determinations of the reported issue could be made.
Event or Problem Description
It was reported that a k-wire tip broke and remains in patient.This event occurred in japan.

• 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: 15994831
• Report Number: 3004142400-2022-00185
• Device Sequence Number: 5672312
• Product Code: LXH
• UDI-Device Identifier: 00849044072105
• UDI-Public: 00849044072105
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 12/07/2022

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: 11/21/2022
• Initial Report FDA Received Date: 12/16/2022
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Patient Race: Asian