MAUDE Adverse Event Report: NUVASIVE, INC. NUVASIVE® PRECEPT¿ SPINAL SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 8801243

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/05/2023

Event Type  malfunction  

Event Description

It was reported the tip of the driver fractured off while final tightening the lock screw; the fractured tip was not recovered and remains lodged in the lock screw.There was no reported adverse patient or procedure impact.No additional information is available.

Manufacturer Narrative

The device was received and the investigation is in progress.A photograph of the device confirms the reported tip fracture.Operative notes, radiograph images, 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.Labeling review: warnings, cautions and precautions: the implantation of spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.Care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient.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.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." upon completion of the investigation and/or if any further, relevant information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

Event Description

New and updated information listed on section h10.

Manufacturer Narrative

The device was received by nuvasive for evaluation and confirmed the complaint.No radiographs were available for review to confirm the location of the un-retrieved fragments.Review of the manufacturing records identified the device was released to the field on aug 29, 2015.Review of the reported event identified the tip splines fractured during final tightening of the lock screw indicating improper use as lock screw starters are not designed to with stand the high torque applied merely to initiate engagement.The root cause of the reported event was identified as end user improper use of a starter to apply final torque and the associated excessive force involved.Additionally the fractured tip per surgeons prerogative was left in the lock screw in-situ no radiographs were provided to confirm location of the fragments and may be a concern for future migration although the stainless steel materials that were un-retrieved can be considered to exert very low toxicity potential and to pose negligible risk to the patient.No additional investigation required.Manufacturing review: review of the device history record notes no material non-conformance, 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: "warnings, cautions and precautions.The implantation of spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient." "compatibility: all implants should be used only with the appropriately designated instrument (reference surgical technique)." "pre-operative warnings 5.Care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient." "method of use please refer to the surgical technique for this device." "information to obtain a surgical technique manual or should any information regarding the products or their uses be required, please contact your local representative or nuvasive directly at +1-800-475-9131.You may also email: info@nuvasive.Com."patient education: preoperative instructions to the patient are essential.The patient should be made aware of the potential risks of the surgery." "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." "pre-operative warnings: the method of use for the instruments are to be determined by the user as 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." (b)(4).

• Brand Name: NUVASIVE® PRECEPT¿ SPINAL SYSTEM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• 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: 17443635
• MDR Text Key: 320243969
• Report Number: 2031966-2023-00155
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00887517351135
• UDI-Public: 887517351135
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: K171894
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8801243
• Device Lot Number: 240787
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/05/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/29/2015
• 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
• Treatment: UNSPECIFIED LOCK SCREW
• Patient Sex: Prefer Not To Disclose