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

Model Number	P12.5-80D335
Medical Device Problem Codes	Crack (1135); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not 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.
Event or Problem Description
It was reported that a precice nail was found cracked post operatively, it had to be removed and replaced.
Event or Problem Description
It was reported that the patient returned for follow up/routine x-rays and dr.(b)(6) noticed a crack in the nail near the male/female junction.Dr.(b)(6) recognized the crack may cause a potential problem so decided to swap for new nail.The crack in nail did not affect patient negatively.
Additional Manufacturer Narrative
The investigation revealed that a precice antegrade femur trochanter, 12.5mm x 335mm nail was reported as having a crack in the nail at the male/female junction.The crack was discovered two months post-op, and the nail was removed and replaced in a revision surgery.The nail was returned to globus medical for investigation.A visual inspection confirmed there are two cracks in the nail on opposite sides of the housing tube at the male/female junction, approximately 7.5mm in length.The cracks confirm the reported defect code of a cracked nail.Additionally, one-half of the anti-rotation lug was missing from the nail.Functional testing was not performed as the missing anti-rotation lug would not allow the nail to properly function.Based on provided information, no event in particular had occurred which could have led to the nail breaking.However, based on the type of breakage observed, it is possible that the nail broke due to stress generated from weight bearing activities.A bending moment is created when weight bearing loads are placed on the distraction rod, causing stress along the housing tube portion where the crown is seated.The wall of the housing tube is thinnest at this location, causing a crack in the tube when enough stress is applied to that location.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 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: 22882593
• Report Number: 3006179046-2025-00116
• Device Sequence Number: 12977029
• Product Code: HSB
• UDI-Device Identifier: 00812258020743
• UDI-Public: 00812258020743
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K220234
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: P12.5-80D335
• Device Lot Number: 4041104
• 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: 05/30/2025
• Supplement Date Received by Manufacturer: 05/30/2025
• Initial Report FDA Received Date: 08/25/2025
• Supplement Report FDA Received Date: 03/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown