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

Model Number	7670214
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No device was returned as the fractured portion remains in patient while the other portion of the device was disposed of at the user facility.A lateral radiograph and a photograph of device were provided confirming the alleged event.The patients bone quality could not be confirmed.Review of the provided information suggests the root cause of the incident to be a result of the casper pin not being fully advanced to the base combined with off angled excessive force allowing the stress concentration point to be at the top of the threaded portion of the device resulting in fracture.No additional investigation can be completed.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." "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 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." "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." (b)(4).
Event or Problem Description
On (b)(6)2022 during an anterior cervical discectomy and fusion procedure a distraction screw fractured in patients bone and could not be retrieved.It currently remains in patient lodged in the bone and was confirmed to be seated flush in bone.There was no adverse consequences to the patient as a result of the failure.No additional action is planned and the surgeon will continue to monitor the patient status.

• Brand Name: NUVASIVE GENERAL INSTRUMENTS
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENTS
• Manufacturer (Section D): NUVASIVE, INCORPORATED; 7475 lusk boulevard; 92121 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: 15169440
• Report Number: 2031966-2022-00140
• Device Sequence Number: 5021769
• Product Code: LXH
• UDI-Device Identifier: 00887517076533
• UDI-Public: 887517076533
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 08/04/2022

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: 7670214
• Device Lot Number: M42776
• 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: 07/08/2022
• Initial Report FDA Received Date: 08/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2019
• 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): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose