MAUDE Adverse Event Report: NUVASIVE SPECIALIZED ORTHOPEDICS, INC. PRECICE® INTRAMEDULLARY LIMB LENGTHENING SYSTEM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	P10.7-80B245
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is unavailable for evaluation.The root cause cannot be determined at this time.A supplemental report will be submitted upon receipt of additional information to support this investigation.
Event or Problem Description
It was reported that the original surgery was performed in october, on (b)(6) 2025.It was a bilateral surgery and two nails were implanted.One was working and the other wasn't, so in november, on (b)(6) 2025, surgery was performed to remove the malfunctioning nail and implant another.This event occurred in spain.
Event or Problem Description
It was reported that the original surgery was performed on (b)(6) 2025.It was a bilateral surgery and two nails were implanted.One was working and the other wasn't, so in november, on (b)(6) 2025, surgery was performed to remove the malfunctioning nail and implant another.This event occurred in spain.
Additional Manufacturer Narrative
The investigation revealed that the complaint was able to be confirmed, but the root cause is unknown.A precice antegrade femur pirformis straight nail, 10.7mm x 245mm (p10.7-80b245, lot # gb1623jac), was returned to globus for investigation.The complaint alleged that the nail failed to distract post operatively.Upon receipt of the device, it was visually inspected where no visible damaged was noted.It was measured to be longer than any minimum length measurement from the lot, showing the nail did distract.X-rays were taken to view the internal components of the nail, but there were no abnormalities noted upon review.The nail then underwent product release testing where it was able to fully distract and retract.The nail was then placed in a distraction force fixture where the nail was unable to meet the minimum distraction force of 180lbs.It was only able to distract with 170lbs of force.The nail was then fully retracted and compressed with the combination of a dowel pin through the distal screw hole and rubber bands.The nail was x-rayed in this compressed state to check the clearance of the internal components, but there was no interference that would cause the nail to be unable to distract while under load.The nail was lastly cut open to view the internal components, but no damaged was noted on any of the components.In conclusion, the complaint for failure to distract can be confirmed as the nail was unable to distract while under load.After reviewing internal x-rays and inspecting the internal subcomponents post nail opening, the cause for this failure is unknown as there is no obvious evidence that suggests the nail would be unable to function as intended.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.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.

• Brand Name: PRECICE® INTRAMEDULLARY LIMB LENGTHENING SYSTEM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• 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: 23697362
• Report Number: 3006179046-2025-00131
• Device Sequence Number: 9152983
• Product Code: HSB
• UDI-Device Identifier: 00812258020255
• UDI-Public: 00812258020255
• Combination Product (Y/N): N
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2026

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: P10.7-80B245
• Device Lot Number: GB1623JAC
• Was Device Available for Evaluation?: Yes
• 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: 11/21/2025
• Supplement Date Received by Manufacturer: 11/21/2025
• Initial Report FDA Received Date: 12/02/2025
• Supplement Report FDA Received Date: 02/10/2026
• 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: Required Intervention
• Patient Sex: Male
• Patient Ethnicity: Hispanic