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

Model Number	P10.7-80B275
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned for evaluation.The root cause is unable to be determined at this time.
Event or Problem Description
Information was received that a revision procedure was performed on an unknown date.As per the reporter, the nail broke due to weight bearing.The nail lengthened successfully and was replaced with a static nail to allow for consolidation of bone regenerate.
Additional Manufacturer Narrative
The nail was received for visual and functional evaluation.Visual inspection of the returned nail revealed that housing tube (had crack at the anti-rotation lug) or the crown region.X-ray images of the internal components revealed the broken anti-rotation lug.The combination of a broken anti-rotation lug and disengagement of retention barbs, results in the loss of distraction.Based on visual inspection and x-ray analyses of the broken nail feature was confirmed.The nail was functionally tested and was not able to distract and retract with the electronic remote controller (erc) and high-speed magnet.The unit was jammed.The unit was unable to pass the functional testing specification.However, based on the type of breakage observed and reported information, it is possible that the housing tube broke due to stress generated from weight bearing activities.Per the precice instructions for use (ifu), the precice stryde nail cannot withstand the stresses of full weight bearing.Patients should utilize external support and/or strict activities as directed by the physician until the consolidation occurs.

• Brand Name: PRECICE SYSTEM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise dr, suite 100; aliso viejo CA 92656
• MDR Report Key: 10956324
• Report Number: 3006179046-2020-00490
• Device Sequence Number: 583842
• Product Code: HSB
• UDI-Device Identifier: 00812258020262
• UDI-Public: 812258020262
• Combination Product (Y/N): N
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: P10.7-80B275
• Device Lot Number: 8110705AAA
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/21/2020
• Supplement Date Received by Manufacturer: 01/19/2021
• Initial Report FDA Received Date: 12/06/2020
• Supplement Report FDA Received Date: 02/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 29 YR
• Patient Weight: 96