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

Model Number	685.007
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/06/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip of the k-wire broke off within the patient and was not retrieved.
Additional Manufacturer Narrative
This report is being resubmitted for an incident that occurred earlier.Evaluation found the revolve k-wire fractured at the tip.It's possible contributing factors of the observed breakage could be variations in wire insertion angle, tap trajectory, and screw insertion trajectory.However, the exact cause of the reported issue cannot be determined.

• Brand Name: REVOLVE
• Common Device Name: 1.6MM NITHINOL 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: 18831308
• Report Number: 3004142400-2018-00055
• Device Sequence Number: 2970544
• 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
• 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): 03/04/2024

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/10/2018
• Initial Report FDA Received Date: 03/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Age: 36 YR
• Patient Sex: Male
• Patient Weight: 67 KG
• Patient Race: Asian