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

Model Number	P8.5-50K190
Medical Device Problem Codes	Break (1069); Collapse (1099)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received that three months after the completion of the lengthening, the femur collapsed 9mm and lost length due to the nail mechanism breaking.The nail has been explanted.
Additional Manufacturer Narrative
The device has not 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.
Event or Problem Description
No additional information has been provided.
Additional Manufacturer Narrative
Device evaluation: upon return, visual inspection of the nail revealed the housing tube had cracks at the anti-rotation lug in the crown region which allowed the distraction rod to rotate freely.X-ray images of the internal components confirmed a broken anti-rotation lug.No other internal damage was found.The nail was functionally tested and was unable to distract or retract with the high-speed magnet for stroke testing.Distraction force testing was measured at 250.7 lbs which meets the specification.The work order was reviewed and confirmed the device passed all inspections per the acceptance tests.The manufacturing x-rays show the anti-rotation lug (crown) was seated properly in the housing body.The inspection data for the lots of the anti-rotation lug and housing tube was reviewed and confirmed the parts met design specifications as per the engineering drawings.Although requested, additional objective evidence has been provided, such as patient x-rays over the treatment process to confirm the reported femur collapse.The failure, therefore, can be confirmed as "broken nail" which was visible during the visual inspection.Based on the investigation, internal x-ray images, and the nature of the observed break, it is likely that the nail broke due to stress generated from patient weight bearing activities.Device labeling: 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.¿ a review of the device history records (dhr) confirmed the device met all quality inspections and specifications prior to release.
Event or Problem Description
No additional information has been provided.

• Brand Name: PRECICE SYSTEM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise dr ste 100; aliso viejo CA 92656
• Manufacturer (Section G): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise dr ste 100; aliso viejo CA 92656
• Manufacturer Contact: geoff gannon ; 101 enterprise dr ste 100; aliso viejo, CA 92656 ; 8583448112
• MDR Report Key: 15303059
• Report Number: 3006179046-2022-00244
• Device Sequence Number: 12383136
• Product Code: HSB
• UDI-Device Identifier: 00812258026189
• UDI-Public: 812258026189
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K191336
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/21/2022

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: P8.5-50K190
• Device Lot Number: 1081308AAA
• 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: 08/16/2022
• Supplement Date Received by Manufacturer: 08/26/2022; 09/20/2022
• Initial Report FDA Received Date: 08/26/2022
• Supplement Report FDA Received Date: 08/28/2022; 09/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/13/2021
• 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: 10 YR
• Patient Sex: Male
• Patient Weight: 48 KG