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

Model Number	P8.5-80D275
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has been received and is pending investigation.X-ray provided confirms the alleged event.A supplemental report will be submitted with device evaluation findings.The reported event has been addressed in the device labeling.
Event or Problem Description
Information was received that a revision procedure was performed on (b)(6) 2020.As per the reporter, during a routine control the surgeon noticed bending on the nail.No patient injury was reported.
Additional Manufacturer Narrative
Evaluation summary: a device history record review found no discrepancies related to the reported event and all lot release criteria were met.Visual inspection of the returned nail revealed that the housing tube was bent in the middle.X-ray imaging inspection was also performed; bending on the housing tube was clear.The nail was functionally tested and was not able to distract or retract with the electronic remote controller and high-speed magnet; the unit was jammed due to the housing tube bending.Based on the damage observed, the x-ray review, and reported information, it is probable that the housing tube bent due to excessive load generated from weight-bearing activities.Per the precice instructions for use, the precice nail cannot withstand the stresses of full weight bearing.Patients should utilize external support or restrict activities as directed by the physician until consolidation occurs.
Event or Problem Description
See updated fields h3, h4, h6, h10.

• 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: 11115021
• Report Number: 3006179046-2021-00100
• Device Sequence Number: 14463599
• Product Code: HSB
• UDI-Device Identifier: 00812258020613
• UDI-Public: 812258020613
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K191336
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2021

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: P8.5-80D275
• Device Lot Number: 0071402AAA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/10/2020
• Supplement Date Received by Manufacturer: 03/05/2021
• Initial Report FDA Received Date: 01/04/2021
• Supplement Report FDA Received Date: 03/17/2021
• 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: 26 YR
• Patient Weight: 40