MAUDE Adverse Event Report: NUVASIVE, INC. NUVASIVE NEXT GENERATION NVM5 SYSTEM; NEUROSURGICAL NERVE LOCATOR

Model Number	50120104
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Following a case in which interoperative neuromonitoring was used, a needle electrode broke off inside the patient's skin during needle removal.The surgeon surgically excised the broken needle to remove it form the patient, which also delayed wakeup by approximately 1 hour.
Additional Manufacturer Narrative
Three (3) radiographs were provided and used to confirm the reported event.Each radiograph showed the fractured portion of the of electrode retained in the patient's skin.Additionally, two (2) photographs of the complaint device were also provided, which showed the electrode wire and connection hub with approximately 1 to 2 mm of the metal electrode tip remaining on the device and the tip of the electrode absent.Based on the information obtained, the root cause of the reported event is unknown, but is likely the result of repeated bending or flexion of the electrode needle during placement and removal combined with handling and electrode removal techniques, which caused a breakage of the solid metal component of the electrode needle.No additional investigation can be completed at this time.Labelling review: "warnings, cautions and precautions.¿proper handling, insertion and placement of electrodes is critical for monitoring." ".Improperly placed or bent needles increase the risk of needle breaking off in the patient." ".Do not attempt to straighten bent needles because this may cause stress and weaken the needle causing it to break off in the patient." "¿do not implant the instruments: complications to the patient may include, but are not limited to.Breakage of the device, which could make necessary removal difficult or sometimes impossible, with possible consequences of late infection and migration.Breakage could cause injury to the patient.Injury that may result from instrument breakage, slippage, misuse, or mishandling.".

• Brand Name: NUVASIVE NEXT GENERATION NVM5 SYSTEM
• Common Device Name: NEUROSURGICAL NERVE LOCATOR
• Manufacturer (Section G): NUVASIVE, INC.; 7475 lusk blvd.; san diego CA 92121
• Manufacturer Contact: geoffrey gannon ; 7475 lusk blvd.; san diego, CA 92121
• MDR Report Key: 16137611
• Report Number: 2031966-2023-00005
• Device Sequence Number: 6610264
• Product Code: PDQ
• UDI-Device Identifier: 00887517939869
• UDI-Public: 887517939869
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K162313
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/11/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/02/2023
• Device Model Number: 50120104
• Device Lot Number: 1110767
• 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: 12/22/2022
• Initial Report FDA Received Date: 01/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NUVASIVE PULSE III SYSTEM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Prefer Not To Disclose