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

Model Number	10000751
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is unavailable for evaluation.No determinations could be made as to the cause of the reported issue.
Event or Problem Description
It was reported that the tip of the reline-o final lock screw driver broke and remained in the implanted screw.This event occurred in spain.
Event or Problem Description
It was reported that the tip of the reline o final lock screwdriver broke and remained in the implanted screw.This event occurred in spain.
Additional Manufacturer Narrative
The investigation revealed the reported complaint as the tip of the reline o final lock screwdriver broke and remained in the implanted screw.The device was not returned for evaluation.No associated torque handle information was provided; the involved devices could not be acquired for review.Although no definitive root cause could be determined, review of the reported event and similar events suggests excessive force, excessive torque and/or fatigue as the likely cause or contributors.The fractured tip per surgeon¿s prerogative was left in-situ and the stainless-steel materials that were unretrieved in this event can be considered to exert very low toxicity potential and to pose negligible risk to the patient.No additional investigation can be completed.A manufacturing review and labeling review were completed.Review of the device history records of all devices notes the device released march 2021, under consignment use for over four years.Additionally, no material non-conformance, no manufacturing errors, nor discrepancies with respect to material type, treatments, dimensions that may have caused or contributed to this mode of failure.Parts met acceptance criteria upon release.A literature review was completed and revealed in situations where the physician has determined that removal of the instrument fragment is not possible and the only safe option is leaving it embedded in the patient, these stainless-steel materials can be considered to exert very low toxicity potential and to pose negligible risk to the patient.A risk evaluation determined a review of the complaint and associated found the effects potentially related to the reported event have been identified and mitigated and the severity of possible effects do not exceed those estimated in the risk documentation.A review of confirmed complaints within the past 24 months of reline final lock screw drivers fracturing intraoperatively leaving an un-retrievable fragment was completed.The product is within the anticipated risk; therefore, the overall risk of the system has been maintained and will continue to be monitored.No new harm event or adverse trend identified with the reported event.

• Brand Name: RELINE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk boulevard; san diego CA 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: 23293187
• Report Number: 2031966-2025-00140
• Device Sequence Number: 20055989
• Product Code: LXH
• UDI-Device Identifier: 00887517513724
• UDI-Public: 00887517513724
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 01/06/2026

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: 10000751
• Device Lot Number: NM4392
• 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: 09/17/2025
• Supplement Date Received by Manufacturer: 09/17/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 01/06/2026
• 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: Unknown