MAUDE Adverse Event Report: NUVASIVE SPECIALIZED ORTHOPEDICS, INC. PRECICE; ANTEGRADE TIBIA, 8.5X215MM

Model Number	P8.5-50C215
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint alleges that the nail was used as a part of a pabst surgery for a distal screw exchange.The nail was distracted 48mm for the initial transport, with the plan being to recharge the nail for an additional 40mm of distraction.There were no complications with distracting the nail, but upon removing the distal screws and attempting a recharge with a pfd2-000 fast distractor max, the nail would not retract at all.The nail was returned to globus medical for investigation.The dhr was reviewed and showed the nail passed all inspections and was manufactured to the specifications that were current at the time of manufacturing.The production x-rays did not present any abnormalities for any nail in the lot.After cleaning, it was measured at 265.22mm.This suggests the nail was fully distracted since this was a 50-stroke nail.X-rays were then taken with one x-ray showing the distraction nut disengaged with the lead screw (see x-ray, "distraction nut and anti-rotation lug").The remaining internal components did not show any defects or damage.The nail was placed in the stroke fixture for retraction where it was able to fully retract to 214.66mm.The nail was then placed in a distraction force fixture where it was unable to produce the required 180lbs of force.Retraction force was unable to be tested.With the nail fully distracted in the patient, what most likely happened was that either with the erc or fast distractor max, the distraction rod became disengaged with the lead screw.With the distal locking screws removed, and the leg in a flexed position, the antegrade nail would have the distraction rod pointing towards the operating table, and gravity would not allow the distraction rod to catch back on to the lead screw, meaning that no matter how long the fast distractor max would use, the lead screw would be rotating, but the distraction rod would not move.When the nail was tested with the stroke test fixture, the nail was placed in the fixture with the distraction rod pointing up, allowing gravity to pull the distraction rod towards the lead screw as it was spinning.This caused the distraction nut to thread with the lead screw, and retraction and distraction could then occur.Rate is within the predicted rated, no new harm determined.The associated risk document was reviewed, and the failure mode, effects, and harms potentially related to the reported 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.The following sections were updated for this supplemental report: b4, d4, d9, e, e2, e3, e4, g3, g6, h2, h3, h6, h10.
Event or Problem Description
Nail failed to retract.Decision taken to remove the nail on later date and insert new nail to continue remaining bone transport.
Event or Problem Description
Nail failed to retract.Decision taken to remove the nail on later date and insert new nail to continue remaining bone transport.
Additional Manufacturer Narrative
The device has not yet been 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.

• Brand Name: PRECICE
• Common Device Name: ANTEGRADE TIBIA, 8.5X215MM
• 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: 22877974
• Report Number: 3006179046-2025-00114
• Device Sequence Number: 10424827
• Product Code: HSB
• UDI-Device Identifier: 00812258020385
• UDI-Public: 812258020385
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: UK
• PMA/510(K) Number: K141023
• 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): 11/14/2025

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: P8.5-50C215
• Device Catalogue Number: P8.5-50C215
• Device Lot Number: 3050807AAA
• 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: 06/12/2025
• Supplement Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 08/22/2025
• Supplement Report FDA Received Date: 11/14/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown