MAUDE Adverse Event Report: NUVASIVE, INC. UNIVERSAL INSERTER, COROENT XL+ SMALL; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	6006618
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the tip of the inserter fractured off in the trial during insertion into l3/4, and the broken piece was lodged in the trial.The trial was then removed from the intervertebral space and no broken fragment was left in-situ.The patient's intervertebral space was reported to be narrow.There was no reported adverse impact to the patient, user, or procedure.No additional information is available.
Additional Manufacturer Narrative
No device was returned for evaluation; however, photographs were provided and confirm the reported event as the inserter tip fracturing at the bottom thread with the fractured portion completely contained within the associated trial.Operative notes and/or medical records were not provided for review of usage/technique; however, the patient's intervertebral space was reported to be narrow.A definitive root cause was unable to be determined but may have been caused by excessive off-axis and/or twisting motion forces being applied during attempted insertion into the reportedly narrow intervertebral space.Manufacturing review: review of the device history record for the device lot identified no relevant material non-conformances, manufacturing errors, nor any discrepancies with respect to material type, treatments, or dimensions that may have caused or contributed to this mode of failure.The lot met acceptance criteria upon release.Labeling review: ".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." ".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." ".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." ".Intra-operative warnings: 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." if any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: UNIVERSAL INSERTER, COROENT XL+ SMALL
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 18167319
• Report Number: 2031966-2023-00271
• Device Sequence Number: 14967750
• Product Code: LXH
• UDI-Device Identifier: 00887517273437
• UDI-Public: 887517273437
• 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): 11/19/2023

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: 6006618
• Device Lot Number: EM1169
• 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: 10/24/2023
• Initial Report FDA Received Date: 11/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• 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: COROENT XL+ TRIAL, 6X18MM, PN 6006806.
• Patient Sex: Prefer Not To Disclose