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

Model Number	P10.7-80D245
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not yet been received for evaluation.The root cause cannot be determined at this time.If any additional information becomes available, a supplemental report will be submitted.
Event or Problem Description
It was reported that a revision surgery to replace a precice nail that was not lengthening occurred.The bilateral nails were implanted on (b)(6) 2025.The right leg is lengthening fine.The left has not moved.We swapped the left leg with a new nail on (b)(6) 2025.
Additional Manufacturer Narrative
The investigation revealed a reported complaint that relates to a precice, antegrade femur, greater trochanter bend, 10.7mm x 245mm nail.The report states that a revision surgery occurred because the nail was not distracting a month after being implanted.There was no patient injury as a result of the reported event.The nail was returned to globus medical for evaluation.A visual inspection did not reveal any physical damage to the exterior of the nail.The nail measured at 247.43mm upon receipt, showing that it had partially distracted while implanted in the patient.X-ray images of the internal mechanism were taken and did not show any discrepancies that would cause the distraction mechanism to fail while in-situ.The nail was then put in the stroke test fixture where it was able to fully distract and retract.The nail was also able to output over 180lbs of force, meeting the production requirements for product lot release.Dhr and production x-rays were reviewed, and it was determined that the device was fully functional before leaving nuvasive.Premature consolidation or soft tissue contraction forces could have caused this nail to not be able to distract.In conclusion, the complaint for failure to distract was not verified due to the fact the device functioned as intended, and no fault was found.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.Rate is within the predicted rated, no new harm determined.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.
Event or Problem Description
It was reported that a revision surgery to replace a precice nail that was not lengthening occurred.

• 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: 23548062
• Report Number: 3006179046-2025-00129
• Device Sequence Number: 21262280
• Product Code: HSB
• UDI-Device Identifier: 00812258020644
• UDI-Public: 812258020644
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2026

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: P10.7-80D245
• Device Lot Number: 4042304
• 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: 08/12/2025
• Supplement Date Received by Manufacturer: 08/12/2025
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 04/22/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Race: White