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

Model Number	D10000332
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient underwent a posterior fixation procedure.During the procedure, after the pedicle screw was attached to the reline mas guide, the guide became stuck and was unable to be disengaged from the screw.The screw and guide were removed and a new screw and guide were used to complete the procedure.There was no report of adverse patient impact as a result of this event.No additional information is available.
Additional Manufacturer Narrative
The reported event was confirmed by review of a photograph showing the mas guide fixed to the screw implant.The image also showed the two inner arm components were misaligned within the outer sleeve, with one of the arms in the locked position and the other halfway between the lock and unlock, indicating that one or both of the inner arms had detached from the proximal locking nut component.The detachment of the inner components would have prevented the arms from being translated as needed to unlock the instrument.No device was returned to nuvasive qa for evaluation; further, operative notes 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 to the locking nut component of the guide.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"."pre-operative warnings: care should be used in the handling and storage of the reline implants.The implants should not be scratched or damaged.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 reusable instruments should be reprocessed using instructions provided below".If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• 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: 17769778
• Report Number: 2031966-2023-00203
• Device Sequence Number: 17801631
• Product Code: LXH
• UDI-Device Identifier: 00887517497383
• UDI-Public: 887517497383
• 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): 09/18/2023

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: D10000332
• Device Catalogue Number: N/A
• Device Lot Number: EM4077
• 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: 08/24/2023
• Initial Report FDA Received Date: 09/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2017
• 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 MAS SCREW.
• Patient Age: 50 YR
• Patient Sex: Male