MAUDE Adverse Event Report: NUVASIVE, INC. RELINE MAS MOD SHANKDRIVER, CANNULATED; STIMULATOR, NERVE

Model Number	D10000955
Medical Device Problem Code	Structural Problem (2506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event was unable to be confirmed due to limited information received from the customer.No device was returned to nuvasive qa for evaluation; further, photographs were not provided for review.Operative notes and/or medical records were not provided for review of usage/technique.A review of the device history record was performed and no discrepancies were found.A definitive root cause was unable to be determined with the information provided.Labeling review: ".Pre-operative warnings - the instruments should be treated as any precision instrument and should be carefully placed on trays, cleaned after each use, and stored, according to generally accepted hospital methods and practices.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 patient injury." ".Cleaning and decontamination - all non-sterile instruments must first be thoroughly cleaned using the validated methods prescribed in the nuvasive cleaning and sterilization instructions (doc #(b)(4)) before sterilization and introduction into a sterile surgical field.Contaminated instruments should be wiped clean of visible soil at the point of use, prior to transfer to a central processing unit for cleaning and sterilization.The validated cleaning methods include both manual and automated cleaning.Visually inspect the instruments following performance of the cleaning instructions to ensure there is no visual contamination of the instruments prior to proceeding with sterilization.If possible contamination is present at visual inspection, repeat the cleaning steps.Contaminated instruments should not be used, and should be returned to nuvasive.Contact your local representative or nuvasive directly for any additional information related to cleaning of nuvasive surgical instruments.Instruments with a ¿d¿ prefix part number (e.G.Dxxxxxxx) may be disassembled.Please refer to the additional disassembly instructions for these instruments." ".Sterilization - all non-sterile instruments are sterilizable by steam autoclave using standard hospital practices, in addition to nuvasive¿s validated parameters.In a properly functioning and calibrated steam sterilizer, effective sterilization may be achieved using the parameters prescribed in the nuvasive cleaning and sterilization instructions (doc #(b)(4))." ".Residual risks to the patient associated with use of general surgical instruments are:.Cleaning and sterilization failures.Which may cause or contribute to infections, fever, wound dehiscence, immunological response and immunological, systemic, or allergic reactions." should any relevant additional information be received, a follow up report will be submitted.
Event or Problem Description
It was reported that during a procedure, the driver's cannulation was found to be clogged with an unidentified material.Another driver was used to successfully complete the procedure.There was no adverse impact to the patient, user, or procedure.No additional information is available.

• Brand Name: RELINE MAS MOD SHANKDRIVER, CANNULATED
• Common Device Name: STIMULATOR, NERVE
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk blvd.; san diego CA 92121
• 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: 18963390
• Report Number: 2031966-2024-00085
• Device Sequence Number: 12802304
• Product Code: ETN
• UDI-Device Identifier: 00887517652065
• UDI-Public: 887517652065
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K112709
• 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): 03/22/2024

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: D10000955
• Device Lot Number: EM4998
• 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: 02/29/2024
• Initial Report FDA Received Date: 03/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/10/2017
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose