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

Model Number	BT115-10X400-7
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The intramedullary nail has broken due to insufficient bone healing.The patient has probably put too much weight on this leg.Date of incident (b)(6) 2026.This event occurred in switzerland.
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.
Event or Problem Description
It was reported that a precice bone transport, retrograde femur nail has broken due to insufficient bone healing.
Additional Manufacturer Narrative
The investigation revealed a complaint relating to a precice bone transport, retrograde femur, 11.5mm x 400mm nail, that was reported as breaking due to insufficient bone healing.It is suspected that the patient was weight bearing more than what is recommended in the ifu.The device was not returned as it was discarded post explantation, so a device evaluation was not possible.However, a device history record (dhr) review was performed for the lot 3060111aaa, and there were no deviations in the manufacturing process, and the finished product met all acceptance criteria prior to shipment.Without further information or the physical device to evaluate, this complaint cannot be confirmed.Because the patient did not follow the surgeon's post-op instructions, it is most likely that the nail failed due to torsional forces exerted on the nail due to weight bearing.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® BONE TRANSPORT 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: 24627662
• Report Number: 3006179046-2026-00105
• Device Sequence Number: 9068691
• Product Code: HSB
• UDI-Device Identifier: 00887517978905
• UDI-Public: 887517978905
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K182170
• 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): 05/06/2026

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: BT115-10X400-7
• Device Catalogue Number: BT115-10X400-7
• Device Lot Number: 3060111AAA
• 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: 03/05/2026
• Supplement Date Received by Manufacturer: 03/18/2026
• Initial Report FDA Received Date: 03/18/2026
• Supplement Report FDA Received Date: 05/06/2026
• 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