MAUDE Adverse Event Report: NUVASIVE, INC. COROENT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	6020040
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The item broke during surgery.No part of the instrument remained inside the patient.This event occurred in spain.
Additional Manufacturer Narrative
The device is unavailable for evaluation.The root cause cannot be determined at this time.If any additional information becomes available, a supplemental report will be submitted.
Additional Manufacturer Narrative
The investigation revealed that the report relates to a nuvasive coroent large mp paddle shaver, 7mm.The report indicates that the instrument fractured during use, and broken pieces had to be removed.There was no patient injury associated with this reported event.The product was not returned for evaluation, but images were provided that visually confirmed the reported complaint.Based on the reported information, the root cause is unknown with a possible root cause of the issue noted as excessive force applied.These devices are subjected to handling after distribution into the field, precautions for which are noted in device labeling.Review of the device history records notes no material non-conformance¿s, no manufacturing errors, nor discrepancies with respect to material type, treatments, dimensions that may have caused or contributed to this mode of failure.Labeling, manufacturing, and risk reviews were completed with no deficiencies, discrepancies or adverse trends noted.Complaint monitoring will continue and additional action will be taken in the event that an adverse trend is identified.No additional action is planned at this time.
Event or Problem Description
The item broke during surgery.No part of the instrument remained inside the patient.

• Brand Name: COROENT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk boulevard; san diego PA 92121
• 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: 23575906
• Report Number: 2031966-2025-00150
• Device Sequence Number: 9577740
• Product Code: LXH
• UDI-Device Identifier: 00887517278074
• UDI-Public: 00887517278074
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2026

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: 6020040
• Device Lot Number: TU5311
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2025
• Supplement Date Received by Manufacturer: 10/21/2025
• Initial Report FDA Received Date: 11/17/2025
• Supplement Report FDA Received Date: 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Female