MAUDE Adverse Event Report: NUVASIVE SPECIALIZED ORTHOPEDICS, INC. PRECICE SYSTEM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	BLD1-012
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	03/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not made available for device evaluation.The root cause is unable to be determined.Device records review: review of the device history record for the blade confirmed that it met all of the required quality inspections prior to release.If any relevant additional information is provided, a supplemental report will be submitted.
Event or Problem Description
Information was received that after the surgeon performed an osteotomy with the 12mm blade, it was discovered that the cutting tip of the blade had deformed during impaction.During confirmation of a completed osteotomy, the surgeon noted a small spiral crack in the bone had propagated from the osteotomy site.No additional information is available.

• Brand Name: PRECICE SYSTEM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise dr, suite 100; aliso viejo CA 92656
• MDR Report Key: 11731667
• Report Number: 3006179046-2021-00261
• Device Sequence Number: 14411232
• Product Code: HSB
• UDI-Device Identifier: 00887517006684
• UDI-Public: 887517006684
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K191336
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: BLD1-012
• Device Lot Number: 9112674
• 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: 03/31/2021
• Initial Report FDA Received Date: 04/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 47 YR