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

Model Number	P10.7-80E245
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a precice nail was implanted on (b)(6) 2022.In (b)(6) 2025, the patient was admitted for an osteotomy due to the breakage of the precice screw and the distal and proximal screws.Fragments extracted, and nail was replaced.
Additional Manufacturer Narrative
The device has not yet been received for evaluation.The root cause cannot be determined at this time.A supplemental report will be submitted upon receipt of additional information.
Additional Manufacturer Narrative
The investigation revealed that the complaint of broken nail is confirmed, and the root cause is unknown.The reported event relates to a nuvasive retrograde femur straight nail, 10.7mm x 245mm (lot#: 1091407aaa).The report indicates that the patient was implanted with the nail on (b)(6) 2022, and on (b)(6) 2025, the patient was admitted for an osteotomy due to a broken nail and broken distal and proximal screws.The nail was removed, but complications arose during the removal due to the lack of instrumentation.There was no patient injury as a result of the reported event.The nail was returned to globus medical for investigation.The nail was broken at the center point of the housing tube, with extensive scratch marks located at the fracture point and distal locking screw holes.It is unknown if these scratches occurred during the removal process.The lead screw disassociated from the thrust bearing and planets assembly, while the locking pin remained in place.Based on the provided x-rays and additional images, the complaint can be confirmed that the nail broke while implanted in the patient.The device's dhr was reviewed, and it was indicated that the nail was manufactured by the specified requirements and met all of the required quality inspections prior to shipment.The iqc inspection report for the lot of housing tube used for the nail was reviewed, and the housing tube met all required specifications per the engineering drawing.Considering the nail was implanted for 3.5 times longer than the recommended maximum length of time of 1 year, it is unlikely the nail breakage was related to any manufacturing processes or material issues.Per lc0305, "device should be removed after implantation time of no more than one year." based on the nail fracture pattern, it is most likely that the nail underwent repeated torsional forces that over an extended period of time, caused the nail to fatigue and eventually fracture along with the screws.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 precice nail was implanted on (b)(6) 2022.On (b)(6) 2025, the patient was admitted for an osteotomy due to the breakage of the precice screw and the distal and proximal screws.Fragments extracted, and nail was replaced.

• 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: 23842504
• Report Number: 3006179046-2025-00137
• Device Sequence Number: 15911474
• Product Code: HSB
• UDI-Device Identifier: 00812258020828
• UDI-Public: 00812258020828
• 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: 2022
• 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): 02/10/2026

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: P10.7-80E245
• Device Catalogue Number: P10.7-80E245
• Device Lot Number: 1091407AAA
• 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: 12/02/2025
• Supplement Date Received by Manufacturer: 12/02/2025
• Initial Report FDA Received Date: 12/18/2025
• 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: Other
• Patient Sex: Unknown