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

Model Number	P10.7-80B305
Medical Device Problem Codes	Failure to Advance (2524); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a revision surgery took place to remove and replace a precice nail that failed to distract.
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.
Additional Manufacturer Narrative
The investigation revealed that a precice ante femur piriformis, 10.7mm x 305mm nail was reportedly not distracting after the patient fell 8 weeks post-op.X-rays reportedly showed that the nail was bent, and the nail would not lengthen.No product was returned.The dhr was reviewed and all documents indicate the device was manufactured by the specified requirements at the time and met all required inspections before shipment.Production x-rays were reviewed with no internal components showing signs of defect.Without further information or the physical device to evaluate, this complaint cannot be confirmed.It's possible the patient falling could have contributed to the bent nail, which could have caused the nail's distraction mechanism to become damaged.Without the nail or x-rays, the 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.
Event or Problem Description
It was reported that a revision surgery took place to remove and replace a precice nail that failed to distract.The patient fell 8 weeks into lengthening.X-rays showed a bent nail.Erc inoperable and nail would not lengthen.

• 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: 22965065
• Report Number: 3006179046-2025-00121
• Device Sequence Number: 9062041
• Product Code: HSB
• UDI-Device Identifier: 00812258020279
• UDI-Public: 812258020279
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 03/03/2026

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: 3103101
• 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: 03/20/2025
• Supplement Date Received by Manufacturer: 03/20/2025
• Initial Report FDA Received Date: 09/04/2025
• Supplement Report FDA Received Date: 03/03/2026
• 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; Required Intervention
• Patient Sex: Unknown