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

Model Number 10001118

Device Problem Contamination (1120)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/28/2023

Event Type  malfunction  

Event Description

On (b)(6) 2023 a patient underwent anesthesia for a scheduled posterior fixation procedure.About 15 minutes into the case it was discovered three of the cement guides were jammed with remnants of cement from a previous case.The surgeon was alerted to the contaminant and made the decision to abandon the procedure as cement augmentation was deemed critical to a successful outcome for the patient.

Manufacturer Narrative

No device was received but photos were provided confirming the alleged complaint.Review of the reported event and information provided identified the failure to release pressure applied to the cement tube resulted in excessive cement being released into the guide as well as insufficient cleaning of the device post use allowing the cement to solidify.If cement is not cleared with the pusher before it hardens in can result in future use error.Device cleaning instructions advise the cement is cleared prior to sterilization.Review of case set history identified the set to be consigned to user facility where cleaning and inspection is the responsibility.Of the end user.No lot code information was provided so a complete manufacturing review could not be completed.Although review of ncmr records and similar events notes no non-conformances with respect to material type, treatments or dimensions that may have caused or contributed to this mode of failure.Parts met acceptance criteria upon release.No additional investigation required.Label review ¿ potential adverse events and complications as with any major surgical procedures, there are risks involved in orthopedic surgery.Infrequent operative and postoperative complications that may result in the need for additional surgeries¿¿ ¿ pre-operative warnings - refer to cleaning and sterilization instructions below for all non-sterile parts¿¿ ¿ 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 #9400896) 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.¿ ¿ sterilization - all non-sterile instruments and implants 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 #9400896).¿ h3 other text : device not returned.

• Brand Name: NUVASIVE RELINE SYSTEM
• Type of Device: 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: geoffrey gannon ; 7475 lusk blvd; san diego, CA 92121
• MDR Report Key: 17821161
• MDR Text Key: 324301583
• Report Number: 2031966-2023-00208
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00887517948397
• UDI-Public: 887517948397
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K223181
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10001118
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose