MAUDE Adverse Event Report: NUVASIVE, INC. NUVASIVE PRECEPT SPINAL SYSTEM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	8801069
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a posterior fixation procedure from l4 to s1.During the procedure, a kirschner wire (k-wire) was inserted into the left s1 and was bent during the placement of the pedicle screw over the wire.Subsequently, the distal tip of the k-wire fractured within the vertebral body and was unable to be removed.As a result, the tip was retained in the patient.No further patient impact was reported.No additional information was provided.
Additional Manufacturer Narrative
No device was returned for evaluation and no photographs or radiographs were provided for review.Based on the information obtained, the complaint was unable to be confirmed and the root cause was unable to be determined; however, it was noted that the distal tip of the k-wire had bent during initial insertion, likely contributing to interference with the tip of the pedicle screw in-situ and causing the device to fracture.There are multiple factors that may have caused the device to bend during insertion including hard/sclerotic bone quality, excessive force, and off-axis force and/or improper technique.Information regarding the patient's bone quality and/or technique used was not provided for review.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." " pre-operative warnings: care should be used in the handling and storage of the precept and precept mas plif implants.Implants and instruments should be protected during storage and from corrosive environments.Care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient." " packaging: packages for each of the components should be intact upon receipt.Devices should be carefully examined for completeness, and for lack of damage, prior to use.Damaged packages or products should not be used, and should be returned to nuvasive.The instruments and implants of the system may be supplied as either sterile or non-sterile.Instruments provided non-sterile can be single-use or reusable.Discard single-use instruments after use.".

• Brand Name: NUVASIVE PRECEPT SPINAL SYSTEM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk boulevard; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INC.; 7475 lusk boulevard; san diego CA 92121
• Manufacturer Contact: patrick yrigoyen ; 7475 lusk boulevard; san diego, CA 92121
• MDR Report Key: 19515819
• Report Number: 2031966-2024-00151
• Device Sequence Number: 18205702
• Product Code: LXH
• UDI-Device Identifier: 00887517346964
• UDI-Public: 887517346964
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 06/11/2024

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: 8801069
• Device Lot Number: SEC015AD
• 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: 05/20/2024
• Initial Report FDA Received Date: 06/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/28/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Sex: Male