MAUDE Adverse Event Report: NUVASIVE, INCORPORATED NUVASIVE RELINE SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	10000409
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	05/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was returned to nuvasive and the device issue could not be confirmed.No photos could be provided confirming injury to the surgeon.Testing of the return device found the level to be performing as intended and kwire was able to pass through without issue.No device problem could be found or recreated indicating the root cause to be the result of inadvertent operator error related to poor handling and or technique related issues.No additional investigation required.Label review "residual risks and potential side effects - as with any major surgical procedures, there are risks involved in orthopedic surgery.Infrequent operative and postoperative complications that may result in.Damage to blood vessels" "residual risks to surgical staff associated with use of general surgical systems are: lacerations, cuts, or abrasions, including due to instrument breakage, slippage, misuse, or mishandling.Instrument failures or malfunctions which prevent intended use, resulting in decreased operational efficiency and general inconvenience." "the instruments should be carefully examined prior to use for functionality, excessive wear, or damage.A damaged instrument should not be used as this may increase the risk of malfunction and potential injury.".
Event or Problem Description
On may 22 2024 it was reported that during a posterior fixation procedure while removing a guidewire the surgeon had difficulty pushing the driver lever to insert the guidewire.As a result the tip of the guidewire pierced the thumb of the surgeon.The bleeding was addressed and the surgeon continued the procedure with no adverse consequences to the patient.

• Brand Name: NUVASIVE RELINE SYSTEM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE, INCORPORATED; 7475 lusk blvd; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INCORPORATED; 7475 lusk blvd; san diego CA 92121
• Manufacturer Contact: patrick yrigoyen ; 7475 lusk blvd; san diego, CA 92121
• MDR Report Key: 19562659
• Report Number: 2031966-2024-00155
• Device Sequence Number: 7680816
• Product Code: NKB
• UDI-Device Identifier: 00887517503862
• UDI-Public: 887517503862
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K223181
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 10000409
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2024
• 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: 05/22/2024
• Initial Report FDA Received Date: 06/18/2024
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Prefer Not To Disclose