MAUDE Adverse Event Report: NUVASIVE, INC. XLIF PITUITARY, MEDIUM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	6940430
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 that the device jaw fractured off during procedure.The broken part was recovered and discarded.There was no report of adverse patient or procedure impact.No additional information is available.
Additional Manufacturer Narrative
The product was received for evaluation and the reported event was confirmed as the upper articulating jaw of the pituitary rongeur being fractured off.It was reported that the jaw of the pituitary rongeur fractured off during use.A definitive cause for the fracture cannot be determined; however, based on previous investigations for similar events, pituitary rongeur jaw fracture can occur when off-axis excessive force and/or twisting motions are placed on the device during use, or can occur as a result of damage accumulated over time and use.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: ".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: XLIF PITUITARY, MEDIUM
• 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: 18167306
• Report Number: 2031966-2023-00270
• Device Sequence Number: 5697375
• Product Code: LXH
• UDI-Device Identifier: 00887517452771
• UDI-Public: 887517452771
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• 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: 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: 6940430
• Device Lot Number: FD3573404
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2023
• 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): Yes
• Date Device Manufactured: 12/05/2013
• 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
• Patient Sex: Prefer Not To Disclose