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	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a revision surgery occurred to remove a precice nail that had broken post operatively.This event occurred in the netherlands.
Additional Manufacturer Narrative
The device has not returned for evaluation.The root cause is unable to be determined at this time.If any additional information is provided, a supplemental report will be submitted.
Additional Manufacturer Narrative
The unit was received by globus medical for in person investigation.Upon return, visual inspection of the returned product confirmed that the housing tube was broken in two pieces, see attached nail - separate x-ray.In addition, provided in-situ x-rays also confirm the reported failure of a broken nail.Upon examining the broken nail closely, further investigation revealed the location where the nail broke is at the point where the screw insert holes are located on each side of the nail.Functional testing and x-ray did not apply due to the nail condition (it was broken).The lot's dhr was reviewed, and it was confirmed that the device passed all inspections and acceptance testing in place at the time of manufacturing.The manufacturing x-rays did not reveal any anomalies that would trigger a part rejection.The inspection data for the lot of housing tubes was reviewed and confirmed that the part met design specifications per the engineering drawings.Because the nail passed all quality inspection/test prior to shipment, it is therefore not likely the breakage was related to any manufacturing processes or material issues.Based on feedback from the sales rep in contact with the surgeon, the patient felt a pop while sitting which most likely was when the breakage occurred.The patient was reportedly compliant and followed the weight bearing protocol outlined in the precice ifu.However, the broken ends of the nail where the screw holes were located were stretched, suggesting that the nail underwent excessive bending, rendering that area of the nail softer and resulting in breakage.The location of the failure (at the two screw hole inserts on each side of the nail) is consistent with what we would expect from a mechanical bending failure in fatigue.It is possible that the nail broke due to stress generated from weight bearing activities.Per the precice instructions for use ¿the precice intramedullary limb lengthening nail cannot withstand the stresses of full weight bearing for tibia and femur applications.For humerus applications, patients should not bear any weight on the treated limb.Patients should utilize external support and/or restrict activities until consolidation occurs.Additionally, based on the in-situ x-rays, the orientation of the proximal portion of the broken nail suggests that a piriformis entrance into the femur was taken, rather than through the greater trochanter.The 10-degree bend of the proximal end of the nail, when implanted through the piriformis fossa, would put additional stress on the nail where the 10-degree bend occurs, which happened to be where the breakage also occurred.Lateral x-rays were not available for this case which would have confirmed the anatomical orientation of the two pieces of the nail.Because the nail has a 10-degree bend, and it appears like it was inserted in the anatomical location meant for a straight nail, this could have exacerbated any bending put on the nail, possibly causing the breakage.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.
Event or Problem Description
The surgeon removed a broken nail.It broke at the distal screw hole of the proximal nail part.The nail has been broken in the patient overtime.This did not happen at surgery or at removal.

• 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): 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: 23006170
• Report Number: 3006179046-2025-00118
• Device Sequence Number: 21459777
• 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
• 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): 11/03/2025

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
• Device Lot Number: 3122023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 07/14/2025
• Supplement Date Received by Manufacturer: 10/31/2025
• Initial Report FDA Received Date: 09/09/2025
• Supplement Report FDA Received Date: 11/03/2025
• 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