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

Model Number	P10.7-80B305
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received that a revision procedure was performed due to the patient experiencing pain and an x-ray image revealing a broken nail.
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.
Additional Manufacturer Narrative
The investigation revealed that a precice antegrade femur, piriformis, straight nail, 80mm x 305mm (lot # 4012611aaa), broke while implanted in the patient.The patient experienced pain in their leg that they associated with lengthening, but upon x-ray review, it was noted that the nail was broken and was replaced with a different, non-precice nail.The nail was sent back for testing, but it could not be located despite attempts to track it down.However, provided x-rays show that the nail in the patient's right leg experienced two failure modes: a broken anti-rotation lug and a backed-out distraction nut.The x-ray confirms the failure mode of a broken nail.The complaint form indicates the patient was ambulating with a walker post-surgery.A broken anti-rotation lug usually indicates excessive weight bearing beyond what is recommended in the instruction for use (ifu).Because the patient is undergoing bilateral femoral lengthening, they would have ambulated on at least one limb undergoing treatment, increasing the likelihood that the nail would have experienced excessive torsional forces, causing a fracture in the anti-rotation lug and rendering the nail broken.A review of the dhr documents indicates the device was manufactured by the specified requirement at the time and met all the required inspections before shipment.The associated risk document was reviewed, and the failure mode, effects, and harms potentially related to the 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.
Event or Problem Description
Information was received that a revision procedure was performed due to the patient experiencing pain and an x-ray image revealing a broken nail.

• Brand Name: PRECICE® INTRAMEDULLARY LIMB LENGTHENING SYSTEM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• 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: 21200478
• Report Number: 3006179046-2025-00100
• Device Sequence Number: 12657069
• Product Code: HSB
• UDI-Device Identifier: 00812258020279
• UDI-Public: 00812258020279
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K220234
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2026

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: P10.7-80B305
• Device Lot Number: 4012611AAA
• 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: 01/12/2025
• Supplement Date Received by Manufacturer: 01/12/2025
• Initial Report FDA Received Date: 01/21/2025
• Supplement Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/26/2024
• 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 Age: 44 YR
• Patient Sex: Male
• Patient Weight: 73 KG