MAUDE Adverse Event Report: NUVASIVE, INC. RELINE; SURGICAL SCREWDRIVER, REUSABLE

Model Number	10000751
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip of the final driver broke off when the surgeon tried the final tightening of the locking screw to connect the spinal rod to the spinal screw.After removing the fragments and tightening with another driver, the surgery was completed.There was no other adverse patient consequences reported.This event occurred in japan.
Additional Manufacturer Narrative
The device is unavailable for evaluation.The root cause cannot be determined at this time.A supplemental report will be submitted upon receipt of additional information to support this investigation.
Event or Problem Description
It was reported that the tip of the reline final driver broke off when the surgeon tried the final tightening of the locking screw to connect the spinal rod to the spinal screw.After removing the fragments and tightening with another driver, the surgery was completed.No other adverse patient consequences reported.
Additional Manufacturer Narrative
The investigation revealed a complaint reporting that a reline final driver broke off when the surgeon tried the final tightening.The subject device was not returned for evaluation; however, photographs of the device were included in the complaint.The photographs included were used to confirm the reported event.A visual evaluation of the images provided allowed for confirmation of the driver distal tip being fractured off of the shank, as reported.The tip was fractured leaving a sub-flush crater consistent with off angle force and/or wear fatigue.No associated torque handle information was provided, and it is unknown if the surgeon utilized free hand tightening.A risk review determined that the severity and rate of occurrence documented in the reported event do not exceed the post-mitigated severity, and failure mode probability, estimated in the risk management file.Following review, no new risk was identified.Labeling, manufacturing, and complaint history reviews were completed with no deficiencies, discrepancies, or adverse trends identified.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.

• Brand Name: RELINE
• Common Device Name: SURGICAL SCREWDRIVER, REUSABLE
• 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: 23935118
• Report Number: 2031966-2025-00172
• Device Sequence Number: 20240328
• Product Code: LXH
• UDI-Device Identifier: 00887517513724
• UDI-Public: 887517513724
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 05/27/2026

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: NM4310
• 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: 12/17/2025
• Supplement Date Received by Manufacturer: 12/17/2025
• Initial Report FDA Received Date: 12/31/2025
• Supplement Report FDA Received Date: 05/27/2026
• 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: Reuse
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Sex: Male