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	10/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient underwent a three (3) level extreme lateral interbody fusion procedure with posterior fixation from l2 to l5.During the procedure, a kirschner wire (k-wire) was inserted into l2 and the pedicle screw was inserted over the wire.Subsequently, the k-wire was attempted to be removed when it was noted to be caught on the tip of the pedicle screw.During several attempts to remove the k-wire, the distal tip 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
The reported event was confirmed by review of photographs of the fractured device and intra-operative radiographs showing the fractured portion of the k-wire within the l2 vertebral body.No device was returned to nuvasive qa for evaluation.A review of the device history record was performed and no discrepancies were found.Information from the representative in the procedure 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.A definitive root cause was unable to be determined with the information provided.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." ".Use lateral fluoroscopy to properly manage the k-wire during pedicle preparation to ensure proper placement and avoid anterior advancement of the k-wire." ".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." if any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• 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: geoff gannon ; 7475 lusk boulevard; san diego, CA 92121
• MDR Report Key: 18031708
• Report Number: 2031966-2023-00244
• Device Sequence Number: 12280585
• 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
• 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): 10/30/2023

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
• Operator of Device: Health Professional
• Device Model Number: 8801069
• Device Catalogue Number: N/A
• Device Lot Number: OB1065
• 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: 10/10/2023
• Initial Report FDA Received Date: 10/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2023
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: RELINE PEDICLE SCREW
• Patient Age: 71 YR
• Patient Sex: Male