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

Model Number	P8.5-80X275
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and is pending 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
Information was received that the nail malfunctioned.No further information has been provided.
Event or Problem Description
No additional information has been provided.
Additional Manufacturer Narrative
Device evaluation: visual inspection of the returned nail revealed the housing tube had cracks at the anti-rotation lug in the crown region and the anti-rotation lug was broken in four pieces which confirmed the reported failure.X-ray images of the internal components confirmed the broken anti-rotation lug.The work order was reviewed and confirmed the device passed all inspections per the acceptance tests.A review of the manufacturing x-ray image showed the anti-rotation lug (crown) was seated properly in the housing body.The inspection data for the lots of anti-rotation lug and housing tube were reviewed and confirmed the parts met design specifications per the engineering drawings.Based on limited information provided and no specific details provided with regard to a cause that may have caused the failure, the exact cause for the confirmed failure mode cannot be determined.However, based on the type of breakage observed, it is possible the nail broke due to stress generated from weight bearing activities.Device records review: a review of the device history records (dhr) confirmed the device met all quality inspections and specifications prior to release.Device labeling: per the precise instructions for use "the precise 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.".

• 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: 16196497
• Report Number: 3006179046-2023-00104
• Device Sequence Number: 4385935
• Product Code: HSB
• UDI-Device Identifier: 00887517935793
• UDI-Public: 887517935793
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K191336
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2023

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: P8.5-80X275
• Device Lot Number: 2051611AAA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2022
• 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: 12/27/2022
• Supplement Date Received by Manufacturer: 01/23/2023
• Initial Report FDA Received Date: 01/18/2023
• Supplement Report FDA Received Date: 01/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2022
• 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: Prefer Not To Disclose