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

Model Number	P10.7-50E215
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/07/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received that after implanting the new nail, an intraoperative test was performed and the nail was not functioning.The surgeon opened the osteotomy site to assure it was complete and freed any soft tissue attachments that may have been interfering with nail function, however, the nail was still unable to move and was then explanted.Nail functionality was confirmed on the back table and was then reimplanted.After further osteotomy site and soft tissue manipulation the nail was able to successfully move the intercalary segment.The nail was tested back and forth a few times to confirm functionality once again and it did not work.The nail was then explanted and replaced.Per the reporter, the explanation for these issues is some sort of unknown patient anatomy that prevented the transport.No additional information has been provided.
Additional Manufacturer Narrative
The device has not been returned for evaluation as it was discarded.The root cause is unable to be determined.

• Brand Name: PRECICE SYSTEM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INCORPORATED; 101 enterprise suite 100; aliso viejo CA 92656
• Manufacturer (Section G): NUVASIVE SPECIALIZED ORTHOPEDICS, INCORPORATED; 101 enterprise suite 100; aliso viejo CA 92656
• Manufacturer Contact: geoff gannon ; 101 enterprise suite 100; aliso viejo, CA 92656 ; 8583448112
• MDR Report Key: 19020633
• Report Number: 3006179046-2024-00122
• Device Sequence Number: 18141035
• Product Code: HSB
• UDI-Device Identifier: 00812258020804
• UDI-Public: 812258020804
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K191336
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/02/2024

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: P10.7-50E215
• 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: 03/12/2024
• Initial Report FDA Received Date: 04/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 27 YR
• Patient Sex: Female