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

Model Number	P8.5-80D245
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is unavailable for evaluation.No determinations could be made as to the cause of the reported issue.
Event or Problem Description
Patient of 15 years old did fall and broke his bone including the precice nail in this event.Revision has taken place on (b)(6) 2025 with a std trauma nail.The lengthening has been achieved with the precice nail.Therefore, a trauma nail has been placed for healing after the break caused by the patient's fall.This event took place in the netherlands.
Additional Manufacturer Narrative
The investigation revealed that the complaint was unable to be confirmed with the information provided and the root cause is unable to be determined.It was reported that a precice nail, p8.5-80d245, was broken after the patient fell and broke their femur.The nail was removed and a trauma nail was inserted since the lengthening and consolidation had been completed.The implant was not returned for evaluation.No lot number was given and therefore, no manufacturing records or quality inspections can be reviewed.Without further information or the physical device to evaluate, this complaint cannot be confirmed.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
Patient of 15 years old did fall and break his bone including the precice nail in this event.Revision has taken place on (b)(6) 2025 with a std trauma nail.The lengthening has been achieved with the precice nail.Therefore, a trauma nail has been placed for healing after the break caused by the patient's fall.This event took place in the netherlands.
Additional Manufacturer Narrative
The investigation revealed that the complaint was unable to be confirmed with the information provided and the root cause is unable to be determined.It was reported that a precice nail, p8.5-80d245, was broken after the patient fell and broke their femur.The nail was removed and a trauma nail was inserted since the lengthening and consolidation had been completed.The implant was not returned for evaluation.No lot number was given and therefore, no manufacturing records or quality inspections can be reviewed.Without further information or the physical device to evaluate, this complaint cannot be confirmed.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
Patient of 15 years old did fall and break his bone including the precice nail in this event.Revision has taken place on (b)(6) 2025 with a std trauma nail.The lengthening has been achieved with the precice nail.Therefore, a trauma nail has been placed for healing after the break caused by the patient's fall.This event took place in the netherlands.

• 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): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 2560 general armistead avenue; audubon PA 19403
• Manufacturer Contact: daniel paul ; 2560 general armistead avenue; audubon, PA 19403 ; 6109301800
• MDR Report Key: 23455532
• Report Number: 3006179046-2025-00125
• Device Sequence Number: 20880054
• Product Code: HSB
• UDI-Device Identifier: 00812258020606
• UDI-Public: 812258020606
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: NL
• PMA/510(K) Number: K220234
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/02/2025

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: P8.5-80D245
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2025
• Supplement Date Received by Manufacturer: 04/17/2025; 04/17/2025
• Initial Report FDA Received Date: 11/03/2025
• Supplement Report FDA Received Date: 12/02/2025; 12/03/2025
• 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 Age: 15 YR
• Patient Sex: Unknown