MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. REVOLVE; ORTHOPAEDIC SURGICAL PROCEDURE KIT, NON-MEDICATED, REUSABLE

Model Number	685.711
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The purpose of this investigation is to evaluate the reported issue of tip fracture.Visual inspection of the imaging provided supports the reported issue that the tip of the k-wire fractured in the patient.Functional inspection was unable to be completed because the part was not returned.Based on the details provided, a l4-5 mis tlif was completed on (b)(6) 2025.Screws were placed at l4 and l5, and an interbody cage was placed in the l4-5 disc space.During the surgery, the tip of the left l5 k-wire broke in the vertebral body and was left in the patient.Due to the inability to replicate surgical conditions and forces experienced by the patient post-op, the exact cause of the failure cannot be determined.The calculated observed risk level matches the expected risk level; therefore, the overall risk of the system has been maintained and there is no further investigation required.
Event or Problem Description
It was reported that a k-wire got jammed up while tapping for screws and surgeon had to forcibly remove the k-wire.He was able to remove it but didn't realize until after he put the screw in that the tip had broken off of the k-wire.X-rays confirmed the tip was left in the vertebral body and didn't exit into the disk space or anteriorly.

• Brand Name: REVOLVE
• Common Device Name: ORTHOPAEDIC SURGICAL PROCEDURE KIT, NON-MEDICATED, REUSABLE
• 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: 23957881
• Report Number: 3004142400-2026-00004
• Device Sequence Number: 9627257
• Product Code: LXH
• UDI-Device Identifier: 00889095740639
• UDI-Public: 00889095740639
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 01/05/2026

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: 685.711
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/08/2025
• Initial Report FDA Received Date: 01/05/2026
• 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 Age: 54 YR
• Patient Sex: Male
• Patient Weight: 125 KG
• Patient Race: White