MAUDE Adverse Event Report: NUVASIVE, INC. MAXCESS DECOMP PITUITARY, 2MM STR; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	1011419
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was initially reported that the pituitary's "closure was no longer effective".No adverse patient, user, or procedure impact was reported.No additional information was made available.Upon evaluation by nuvasive servicing personnel, it was found the upper jaw tip was fractured off.
Additional Manufacturer Narrative
The device was returned and nuvasive service personnel examined the device.Examination of the returned device identified the upper distal biting jaw had fractured off.Although a definitive cause cannot be determined, the reported event, service findings, and previous complaints of a similar nature suggest the fracture was the result of excessive forces being applied to the upper biting jaw.It is unknown if the fractured piece was removed from the patient as no additional information was received.Manufacturing review: review of the device history record notes no material non-conformances, no manufacturing errors, and no discrepancies with respect to material type, treatments, dimensions that may have caused or contributed to this mode of failure.The lot 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." "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¿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.Care should be used during surgical procedures to prevent damage to the devices and injury to the patient." "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.".

• Brand Name: MAXCESS DECOMP PITUITARY, 2MM STR
• 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: 17280003
• Report Number: 2031966-2023-00139
• Device Sequence Number: 5184319
• Product Code: LXH
• UDI-Device Identifier: 00887517065834
• UDI-Public: 887517065834
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 07/07/2023

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: 1011419
• Device Lot Number: FD8211704
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2023
• 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: 06/14/2023
• Initial Report FDA Received Date: 07/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/21/2018
• 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