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

Model Number	P10.7-80B305
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2025
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
Implanted precise nail broken, revision procedure completed to remove and replace.
Event or Problem Description
It was reported that there was an implanted precice nail broken, revision procedure completed to remove and replace.
Additional Manufacturer Narrative
The nail was received at globus medical and underwent a visual inspection where no visible defects were found.The nail was received at a length of 350.19mm, showing the nail was able to distract prior to being returned to globus.X-rays of the nail were taken with no discrepancies found with any of the internal components.The dhr for the lot was reviewed and no discrepancies were found.All 17 nails in the lot passed functional acceptance testing and quality inspection.Production x-rays were reviewed for the released nails with no discrepancies or abnormalities noted.The complaint alleged that the nail was unable to distract at a 1mm:1mm ratio with the erc, but the contralateral nail in the left femur was distracting at a 1mm:1mm ratio with the erc.An in-house erc1 was programmed to distract the nail 2mm.After the distraction session, the nail measured 352.11mm for a distraction length of 1.92mm.This is within an erc's distraction accuracy specification of ±10% + ±0.30mm, which for a 2mm distraction would be 2mm ±0.5mm.The nail was able to fully distract and retract with the use of the stroke test fixture, and it was also able to generate the required minimum 180lbs of force needed for production release testing.The nail was cut open with the use of a lathe for a final visual check on the internal components, but no discrepancies or abnormalities were found.These tests suggest that the nail is functioning according to its specifications and the complaint is unable to 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.Complaint monitoring will continue and additional action will be taken in the event that an adverse trend is identified.No additional action is planned at this time.

• Brand Name: PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk boulevard; san diego CA 92121
• 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: 23183495
• Report Number: 3006179046-2025-00123
• Device Sequence Number: 10074719
• Product Code: HSB
• UDI-Device Identifier: 00812258020279
• UDI-Public: 812258020279
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2026

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: P10.7-80B305
• Device Lot Number: GB1607VAC
• 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: 09/02/2025
• Supplement Date Received by Manufacturer: 01/20/2026
• Initial Report FDA Received Date: 09/30/2025
• Supplement Report FDA Received Date: 01/20/2026
• 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
• Patient Sex: Unknown