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

Model Number HD203T25

Device Problem Fracture (1260)

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

Event Date 10/29/2021

Event Type  malfunction  

Event Description

On (b)(6) 2021, a patient underwent a revision procedure to remove a previously implanted competitors screw.During the procedure the tip of the nuvasive removal tool that was being used fractured off and was retrieved but no additional replacement instrument was available.The case was delayed for about 30 minutes before it was decided to cancel.An additional revision surgery is being planned but is not scheduled at this time.

Manufacturer Narrative

No product was returned as the device was disposed of at the facility but a photograph was provided confirming the alleged driver tip fracture.No adverse effects to the patient reported.A bone quality report could not be provided.Review of the reported event identified that the nuvasive was being utilized with another manufactures implant which is considered to be off labeled usage as device compatibility is unknown while utilizing with competitors devices.No additional investigation needed.Label review: "compatibility: do not use nuvasive instruments with components of other systems.Unless stated otherwise, nuvasive devices are not to be combined with the components of another system." "care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient.".

Event Description

Corrected information listed in h10.

Manufacturer Narrative

No product was returned as the device was disposed of at the facility, a photograph was provided confirming the driver tip fracture.Examination of the provided photograph noted what appears to be a high load torsional fracture and likely the result of excessive torque.A bone quality report could not be provided.Review of the reported event identified that the nuvasive was being utilized with another manufactures implant for which requirements for are unknown.No adverse effects to the patient reported.Labeling review: "pre-operative warnings: the method of use for the instruments are to be determined by the user¿s experience and training in surgical procedures.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.Care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient." "intra-operative warnings: the physician should take precautions against putting undue stress on the spinal area with instruments.Any surgical technique should be carefully followed.It is important that the surgeon exercise extreme caution when working in close proximity to vital organs, nerves, or vessels, and that the force applied to the instrumentation is not excessive, to prevent potential injury to the patient.Over-bending, notching, striking, and/or scratching of implants with any instrument should be avoided to reduce the risk of breakage.When using the maxcess mas tlif system for distraction care must be taken to avoid damaging the pedicles which could compromise pedicle screw purchase.The physical characteristics required for many instruments do not permit them to be manufactured from implantable materials.If any broken fragments of instruments remain in the body of a patient, they could cause allergic reactions or infections.If an instrument breaks in surgery and fragments go into the patient, these pieces should be removed prior to closure and should not be implanted." "care should be used during surgical procedures to prevent damage to the device(s) 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.".

• Brand Name: NUVASIVE GENERAL INSTRUMENTS
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENTS
• Manufacturer (Section D): NUVASIVE, INCORPORATED; 7475 lusk boulevard; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INCORPORATED; 7475 lusk boulevard; san diego CA 92121
• Manufacturer Contact: geoff gannon ; 7475 lusk boulevard; san diego, CA 92121
• MDR Report Key: 12747329
• MDR Text Key: 282711643
• Report Number: 2031966-2021-00151
• Device Sequence Number: 1
• Product Code: LHX
• UDI-Device Identifier: 00887517476005
• UDI-Public: 887517476005
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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,Followup
• Report Date: 01/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HD203T25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/28/2022
• 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: Reuse
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 90 KG