MAUDE Adverse Event Report: NUVASIVE INC NUVASIVE GENERAL INSTRUMENTS; ORTHOPEDIC MANUAL SURGICAL INSTRUMENTS

Model Number 3240121

Device Problems Mechanical Problem (1384); Unintended Movement (3026)

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

Event Date 03/10/2023

Event Type  malfunction  

Event Description

During a spinal procedure it was reported that the device would not tighten.No additional information was received.

Manufacturer Narrative

The device was returned and the complaint was confirmed.Device history report review of the reported device identified with release to the field in 2012.Examination of the returned device was completed by nuvasive where the locking mechanism was found to be worn and sloppy from excessive use which was determined to be the root cause.No patient injury was reported.No additional investigation necessary.Manufacturing review: review of the device history record notes no material non-conformance¿s, no manufacturing errors, nor discrepancies with respect to material type, treatments, dimensions that may have caused or contributed to this mode of failure.Parts met acceptance criteria upon release.Labeling 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 the need for additional surgeries include: early or late infection; damage to blood vessels, spinal cord or peripheral nerves; pulmonary emboli; loss of sensory and/or motor function; impotence; and permanent pain and/or deformity.Rarely, some complications may be fatal.Residual risks to the patient associated with use of general surgical instruments are: cleaning and sterilization failures, sterile barrier compromise, corrosion, and unretrieved instrument fragments which may cause or contribute to infections, fever, wound dehiscence, immunological response and immunological, systemic, or allergic reactions.In some instances, treatment of these events may require surgical intervention including revision surgery.Skin irritation, rash, sensitization and/or cell death which may occur in the event a patient is allergic to a material used in the system instruments.Instrument malfunctions which potentially result in surgical delays (thereby causing additional exposure to anesthesia, blood loss, and infection), a change in surgical plan, failure to achieve optimal clinical result and/or, infrequently, cancellation of a procedure.Such malfunctions include instrument fracture, which could make necessary removal difficult or sometimes impossible, with possible consequences of late infection and migration; instrument fracture may also result in injury to the patient.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.Physical injury that may result from the disassembly of multi-component instruments occurring during surgery.Instrument failures or malfunctions which prevent intended use, resulting in decreased operational efficiency and general inconvenience." ".Patient education: preoperative instructions to the patient are essential.The patient should be made aware of the potential risks of the surgery.".".Pre-operative warnings: the method of use for the instruments are to be determined by the user¿s experience and training in surgical procedures.Do not use these instruments for any action for which it was not intended such as hammering, prying, or lifting.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.Surgical grade instrument lubrication should be applied to all moving components during the wash and sterilization cycle to ensure proper functionality.Instruments should be protected during storage and from corrosive environments.Refer to cleaning and sterilization instructions below for all non-sterile parts.Care should be used during surgical procedures to prevent damage to the devices and injury to the patient.".".Method of use: if there is any doubt or uncertainty concerning the proper use of instruments please contact nuvasive customer service.Any available surgical techniques will be provided upon request.For optimal results, the same type of instruments used for implantation should be used for implant removal.".".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.".

• Brand Name: NUVASIVE GENERAL INSTRUMENTS
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENTS
• 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: geoff gannon ; 7475 lusk blvd; san diego, CA 92121
• MDR Report Key: 16693967
• MDR Text Key: 312875171
• Report Number: 2031966-2023-00065
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 00887517196668
• UDI-Public: 887517196668
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/06/2023

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
• Device Operator: Health Professional
• Device Model Number: 3240121
• Device Lot Number: NS23989
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/14/2023
• Initial Date FDA Received: 04/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/22/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose