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

Model Number	P8.5-80D245
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Precice nail was tested with fast distractor, and the nail did not move.We tried several times and suddenly the thinner part of the nail plobbed out about 2cm.After that, you could by hand move the thinner part of the nail back and forth.The nail was still implanted due to lack of alternatives.The surgeon is discussing with colleagues about further actions.This event occurred in germany.
Additional Manufacturer Narrative
The device is unavailable for evaluation as it remains in situ.The root cause cannot be determined at this time.If any additional information becomes available, a supplemental report will be submitted.
Additional Manufacturer Narrative
The investigation revealed that the that the reported event relates to a precice ante femur troch, 8.5x245mm.The report indicates that the nail would not distract with the use of a fast distractor.After several attempts, the nail eventually experienced uncontrolled distraction with the distraction rod able to piston in two directions.No product was returned, and the complaint could not be confirmed.Without further information or the physical device to evaluate, this complaint cannot be confirmed.The internal threading mechanism would've had to have experienced a high level of torque for the threads to shear and that could possibly allow the distraction rod to move freely in addition to a connection failure somewhere below the thrust bearing.Without the nail, this cause cannot be confirmed.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.Complaint monitoring will continue and additional action will be taken in the event that an adverse trend is identified.No additional action is planned at this time.
Event or Problem Description
Precice nail was tested with fast distractor, and the nail did not move.We tried several times and suddenly the thinner part of the nail plobbed out about 2cm.After that, you could by hand move the thinner part of the nail back and forth.The nail was replaced with a new working precice nail with reported good outcome.This revision took place on (b)(6) 2025.This event occurred in germany.

• 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: 23513257
• Report Number: 3006179046-2025-00127
• Device Sequence Number: 9770261
• Product Code: HSB
• UDI-Device Identifier: 00812258020606
• UDI-Public: 00812258020606
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: GM
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2026

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: P8.5-80D245
• Device Lot Number: GB161FSY
• 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: 10/30/2025
• Supplement Date Received by Manufacturer: 10/30/2025
• Initial Report FDA Received Date: 11/10/2025
• Supplement Report FDA Received Date: 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Female