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

Model Number	P12.5-80B335
Medical Device Problem Codes	Failure to Advance (2524); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a precice nail was not lengthening intra-operatively, it was removed and replaced.
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, 12.5mm x 335mm was reported as being unable to distract in-situ.After being removed from the patient, the nail was able to distract with the use of a fast distractor.The nail was returned to globus medical for investigation.Upon receipt of the nail, it was measured at 339.71mm.This confirms that the nail was able to distract with the fast distractor as reported.The nail was x-rayed and there was no sign of damage or defects with any of the nail's internal components.Functional testing per at0036 was performed.The nail was able to fully distract and retract, reaching a maximum and minimum stroke lengths of 415.39mm and 334.03mm, respectively.The nail's distraction force was also tested, and it was able to produce 190lbf, exceeding the minimum acceptable force of 180lbf.A review of the dhr documents and production x-rays indicates the nail was manufactured by the specified requirement at the time and met all the required inspections before shipment.The nail has performed as expected with no reported failure confirmed, therefore, no root cause can be 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
The nail was not lengthening when tested after insertion.We tried 2 ercs with no sign of lengthening on x-ray.We had to exchange the nail - once we removed, we tested the nail with a blue fast distractor on the back table and the nail was functional.

• 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: 22882686
• Report Number: 3006179046-2025-00115
• Device Sequence Number: 8861150
• Product Code: HSB
• UDI-Device Identifier: 00812258020354
• UDI-Public: 00812258020354
• 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: Company Representative
• 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: P12.5-80B335
• Device Lot Number: GB1611PX
• 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: 05/28/2025
• Supplement Date Received by Manufacturer: 05/28/2025
• 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