MAUDE Adverse Event Report: NUVASIVE, INC. NUVASIVE RELINE MAS SYSTEM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	10000750
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No device was returned to nuvasive for evaluation; the reported event was confirmed by review of a photograph of the fractured device.The torque handle used, operative notes, and/or radiograph images were not provided for review of usage/technique.A review of device manufacturing records was performed and no discrepancies relevant to the reported event were found.A definitive root cause was unable to be determined with the information provided; however, may have resulted from excessive force applied by the torque handle or the user.Labeling review: "pre-operative warnings: implants and instruments should be protected during storage and from corrosive environments.Refer to cleaning and sterilization instructions below for all non-sterile parts.Care should be used during surgical procedures to prevent damage to the device(s) and 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.Surgical grade instrument lubrication should be applied to all moving components during the wash and sterilization cycle to ensure proper functionality.Care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient" "intra-operative warnings: the physician should take precautions against putting undue stress on the spinal area with instruments.Any surgical technique should be carefully followed.It is important that the surgeon exercise extreme caution when working in close proximity to vital organs, nerves, or vessels, and that the force applied to the instrumentation is not excessive, to prevent potential injury to the patient.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.
Event or Problem Description
During a procedure, the driver tip fractured off while final tightening the lock screw.The fractured portion could not be retrieved and therefore remains in the patient; however, the fractured portion was reported to be lodged within the lock screw.There was no delay in surgery and there has been no report of adverse patient impact as a result of this event.No additional information is available.

• Brand Name: NUVASIVE RELINE MAS 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: 17007269
• Report Number: 2031966-2023-00120
• Device Sequence Number: 20407214
• Product Code: LXH
• UDI-Device Identifier: 00887517513717
• UDI-Public: 887517513717
• Combination Product (Y/N): N
• Initial Reporter Country: LO
• 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): 05/25/2023

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: 10000750
• Device Catalogue Number: N/A
• Device Lot Number: NM3941
• 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: 05/03/2023
• Initial Report FDA Received Date: 05/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2020
• 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: Unknown
• 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 LOCK SCREW
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 90 KG