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

Model Number	P12.5-80D305
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned for evaluation.The root cause is unable to be determined at this time.If any additional information is provided, a supplemental report will be submitted.The revision surgery was completed with no issue or adverse consequences to the patient.
Event or Problem Description
Information was received that during an implant procedure the nail was tested with the electronic remote controller (erc) on the back table and it was able to distract.The patient's tissue gap was normal and it was confirmed via fluoroscopy.When testing the nail while the patient is on the table, the nail was unable to distract while using the fast distractor max.Two hours of testing was performed and it was decided to exchange the nail and the pegs to prevent a possible infection.The surgery was completed with no issue or adverse consequences to the patient.The removed nail was tested with ls fast distractor max and after several very loud "clacks" the nail starts to move as if it were stuck at some point.Complaint 1 of 2.
Event or Problem Description
No additional information has been provided.
Additional Manufacturer Narrative
A review of the device history record (dhr) found no inconsistencies.While production x-rays were not identified, all functional testing data and acceptance criteria were recorded as passing.Upon receipt, the device was measured at 309.61mm.The longest recorded length of the nail at the time of manufacturing was 304.57mm, indicating that lengthening had occurred.Verification testing using a fast distractor confirmed that the nail was capable of lengthening.Additionally, when placed in the force test fixture, the nail met the minimum output requirement.Based on these findings, the root cause of the failure to distract remains undetermined.The issue could not be replicated, and all testing suggests that the nail is fully operational.

• Brand Name: PRECICE INTRAMEDULLARY LIMB LENGTHENING 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: patrick yrigoyen ; 101 enterprise suite 100; aliso viejo, CA 92656 ; 8583442667
• MDR Report Key: 19693490
• Report Number: 3006179046-2024-00140
• Device Sequence Number: 8027459
• Product Code: HSB
• UDI-Device Identifier: 00812258020736
• UDI-Public: 812258020736
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K220234
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2025

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: P12.5-80D305
• Device Lot Number: 4052412AAA
• Was Device Available for Evaluation?: Yes
• 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: 06/17/2024
• Supplement Date Received by Manufacturer: 01/29/2025
• Initial Report FDA Received Date: 07/08/2024
• Supplement Report FDA Received Date: 02/03/2025
• Date Device Manufactured: 05/24/2024
• 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
• Patient Sex: Male