MAUDE Adverse Event Report: NUVASIVE, INCORPORATED NUVASIVE PRECEPT SCREW SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	8801069
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product evaluation can be completed as no product was returned.No images provided to confirm the malfunction.Due to lack of information the root cause cannot be determined and no additional investigation can be completed.Labeling review: ".Warnings, cautions, and precautions: use lateral fluoroscopy to properly manage the k-wire during pedicle preparation to ensure proper placement and avoid anterior advancement of the k-wire." ".Pre-operative warnings: care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient.".
Event or Problem Description
A 1.5mm piece of k-wire broke off in patient's sacrum during a spinal case.Surgeon was attempting to drill k-wire into sacrum.

• Brand Name: NUVASIVE PRECEPT SCREW SYSTEM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE, INCORPORATED; 7475 lusk boulevard; san diego CA 92121
• MDR Report Key: 11595856
• Report Number: 2031966-2021-00047
• Device Sequence Number: 3606134
• Product Code: NKB
• UDI-Device Identifier: 00887517346964
• UDI-Public: 887517346964
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K171894
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/31/2021

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: 8801069
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2021
• Initial Report FDA Received Date: 03/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1