MAUDE Adverse Event Report: NUVASIVE, INCORPORATED NUVASIVE GENERAL INSTRUMENTS; ORTHOPEDIC MANUAL SURGICAL INSTRUMENTS

Model Number	6940430
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2022 a patient underwent an extreme lateral interbody fixation procedure.During the procedure while removing tissue from the disc space the upper distal biting jaw fractured off.All pieces were retrieved without injury or adverse consequences to the patient.
Additional Manufacturer Narrative
The device was returned on (b)(6) 2022 and the complaint was confirmed.Evaluation of the returned device identified excessive wear fatigue, manufacturing review identified the device was release into the field in january of 2015 and is considered the root cause no additional investigation required.Label review: "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.Physical injury that may result from the disassembly of multi-component instruments occurring during surgery.Injury that may result from instrument breakage, slippage, misuse, or mishandling." "pre-operative warnings: do not use these instruments for any action for which it was not intended such as hammering, prying, or lifting.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.".

• Brand Name: NUVASIVE GENERAL INSTRUMENTS
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENTS
• Manufacturer (Section D): NUVASIVE, INCORPORATED; 7475 lusk boulevard; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INCORPORATED; 7475 lusk boulevard; san diego CA 92121
• Manufacturer Contact: geoff gannon ; 7475 lusk boulevard; san diego, CA 92121
• MDR Report Key: 14594371
• Report Number: 2031966-2022-00109
• Device Sequence Number: 2239048
• Product Code: LHX
• UDI-Device Identifier: 00887517452771
• UDI-Public: 887517452771
• Combination Product (Y/N): N
• Initial Reporter State: VT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/03/2022

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: 05/17/2022
• 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: 05/11/2022
• Initial Report FDA Received Date: 06/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2015
• 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
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose