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	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device remains in situ but may be removed in a future revision.The root cause cannot be determined at this time.A supplemental report will be submitted upon receipt of additional information.
Event or Problem Description
It was reported by the surgeon that the precice nail is very bent and requires revision surgery to replace nail.The nail remains in situ.
Additional Manufacturer Narrative
The investigation revealed that a precice model p8.5-80d245 was reported to have bent in the actuator region of the nail.No product was returned, but the provided x-ray does confirm that the nail was bent outside of its specifications.No lot number was provided so the device history record cannot be reviewed for the lot's quality inspections and specifications.The information has been added to the database for tracking and trending purposes.Trends will continue to be monitored.Without the device, a reported failure of a damaged implant cannot be confirmed.However, with the provided patient x-ray, the alternate observation of a bent nail can be confirmed.The patient was reportedly non-weight bearing, so a probable cause could be muscle contraction forces in the vastus medialis pulling the distal bone segment proximally, causing a varus deformity.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 by the surgeon that the precice nail is very bent and requires revision surgery to replace nail.The nail remains in situ with plan for removal.

• 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: 24021669
• Report Number: 3006179046-2026-00100
• Device Sequence Number: 16090670
• Product Code: HSB
• UDI-Device Identifier: 00812258020606
• UDI-Public: 00812258020606
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K220234
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 02/26/2026

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: P8.5-80D245
• 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: 01/02/2026
• Supplement Date Received by Manufacturer: 01/02/2026
• Initial Report FDA Received Date: 01/09/2026
• Supplement Report FDA Received Date: 02/26/2026
• 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
• Patient Sex: Unknown