MAUDE Adverse Event Report: NUVASIVE SPECIALIZED ORTHOPEDICS, INC. PRECICE® INTRAMEDULLARY LIMB LENGTHENING SYSTEM; FEMUR INTRAMEDULLARY NAIL

Model Number	P12.5-80A275
Medical Device Problem Codes	Break (1069); Unintended System Motion (1430)
Health Effect - Clinical Code	Atrial Fibrillation (1729)
Date of Event	08/06/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was returned to the manufacturer and the device evaluation findings are not yet available.No x-rays or ultrasound images provided to confirm the alleged event.No root cause can be confirmed at this time.
Event or Problem Description
Information was received indicating that the patient was positioned on the side of the tub when they attempted to stand and experienced an audible pop, accompanied by a sensation of structural compromise.Subsequent x-ray imaging suggested the presence of a fractured crown.Over the following weeks, the patient¿s nail exhibited progressive shortening.To address this, the patient utilized the electronic remote controller (erc) to restore the appropriate length.Ultimately, a revision procedure was performed to replace the existing nail with a static nail.Postoperatively, the patient was admitted to the intensive care unit (icu) for overnight observation due to atrial fibrillation (afib) precipitated by the surgical intervention.
Event or Problem Description
Information was received indicating that the patient was positioned on the side of the tub when they attempted to stand and experienced an audible pop, accompanied by a sensation of structural compromise.Subsequent x-ray imaging suggested the presence of a fractured crown.Over the following weeks, the patient¿s nail exhibited progressive shortening.To address this, the patient utilized the electronic remote controller (erc) to restore the appropriate length.Ultimately, a revision procedure was performed to replace the existing nail with a static nail.Postoperatively, the patient was admitted to the intensive care unit (icu) for overnight observation due to atrial fibrillation (afib) precipitated by the surgical intervention.
Additional Manufacturer Narrative
The investigation revealed that a precice retrograde femur, straight 80mm x 275mm (lot 4060501aaa), lost distraction after a patient was getting out of a bathtub and stood on the treated limb.The patient felt and heard a pop, and over the course of a few weeks, the patient's nail shortened and x-ray showed a broken crown.The patient underwent a surgery to remove the affected nail and implant a static nail.The patient spent the night in the icu due to atrial fibrillation brought on by the surgery.The nail was received by globus medical for evaluation.The nail was received in a distracted state with the crown component detached from the proximal portion of the nail.X-rays were taken and showed no damage or issues with any of the internal components other than the missing crown.Functional testing was not performed as the lack of a crown would not have allowed the distraction rod to distract and it would instead spin in the housing tube.A review of the dhr documents indicates the device was manufactured by the specified requirement at the time and met all of the required inspections before shipment.Production x-rays were reviewed with no issues or discrepancies found.Because the starting and ending lengths of the nail prior to and after the event are unknown, it cannot be confirmed that the nail lost distraction.However, due to the broken crown component, the event of a broken nail can be confirmed with the cause of the patient exceeding the weight bearing limits found in the product's ifu.The associated risk document was reviewed, and the failure mode, effects, and harms potentially related to the reported event have been identified and mitigated.Furthermore, the complaint rate is within the estimated rate in the risk documentation associated with this product.Based on this risk assessment, no new or additional risk evaluation is necessary.

• Brand Name: PRECICE® INTRAMEDULLARY LIMB LENGTHENING SYSTEM
• Common Device Name: FEMUR INTRAMEDULLARY NAIL
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 2560 general armistead avenue; audubon PA 19403
• Manufacturer (Section G): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon PA 19403
• Manufacturer Contact: daniel paul ; 2560 general armistead avenue; audubon, PA 19403 ; 6109301800
• MDR Report Key: 21459934
• Report Number: 3006179046-2025-00104
• Device Sequence Number: 7781717
• Product Code: HSB
• UDI-Device Identifier: 00812258020156
• UDI-Public: 00812258020156
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2026

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: P12.5-80A275
• Device Lot Number: 4060501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2025
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2025
• Supplement Date Received by Manufacturer: 02/17/2025
• Initial Report FDA Received Date: 02/25/2025
• Supplement Report FDA Received Date: 03/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2024
• 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 Sex: Male