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

Model Number	P10.7-50E215
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not yet been received for evaluation.The root cause cannot be determined at this time.If any additional information becomes available, a supplemental report will be submitted.
Event or Problem Description
It was reported that a precise nail was broken when it was incorrectly compressed, it was removed and replaced.
Event or Problem Description
It was reported that a precice nail broke when it was incorrectly compressed, it was removed and replaced.
Additional Manufacturer Narrative
The investigation revealed that a precice retrograde femur, straight, 10.7mm x 215mm nail was reported as malfunctioning after the patient's prescription was incorrectly set-up by a member of the sales team.The nail was compressed instead of distracted due to the incorrect prescription.After correcting the prescription programmed in the patient's erc, the nail was unable to distract and was eventually swapped with a new nail in a revision surgery.The nail was unable to be returned to globus medical for investigation.The reporter is no longer an employee of the company, and the nail could not be located.Based on the event evaluation form provided by the reporter, it is plausible that the sales team member, who inputted the prescription, accidentally input the prescription for an antegrade nail instead of a retrograde nail.Using a prescription for an antegrade nail with an implanted retrograde nail would cause the nail to compress instead of distract.A nail experiencing compression with a high level of torque could flatten the anti-jam washer and cause the nail to no longer be able to distract.However, without the nail, this cannot be confirmed.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: 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: 23057358
• Report Number: 3006179046-2025-00122
• Device Sequence Number: 15624659
• Product Code: HSB
• UDI-Device Identifier: 00812258020804
• UDI-Public: 00812258020804
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K141023
• 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): 08/19/2025

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: P10.7-50E215
• Device Lot Number: 3120543AAA
• 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: 08/19/2025
• Supplement Date Received by Manufacturer: 08/19/2025
• Initial Report FDA Received Date: 09/15/2025
• Supplement Report FDA Received Date: 04/01/2026
• 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