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

Model Number	PS11.5-80D280
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device has not yet been returned.Root cause is not available at this time.
Event or Problem Description
Information was received that a revision procedure was performed on an unknown date.The patient had a nail break earlier this year.No patient injury was reported.
Additional Manufacturer Narrative
The nail was received for visual and functional testing.Visual inspection confirmed that the nail was broken at the top housing tube below the second hole.The condition of the nail did not allow for functional testing.Based on the reported information, the patient did not comply with the instructions for use (ifu) that states that patients should utilize external support and/or restrict activities as directed by the physician until consolidation occurs.As part of the investigation, the device history records were reviewed and no discrepancies were found.The device was manufactured in accordance with the specified requirement and met all of the required quality inspections.

• Brand Name: PRECICE STRYDE 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: 10292098
• Report Number: 3006179046-2020-00342
• Device Sequence Number: 11607197
• Product Code: HSB
• UDI-Device Identifier: 00887517951267
• UDI-Public: 887517951267
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K180503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2020

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: PS11.5-80D280
• Device Lot Number: 9011721AAA
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/17/2020
• Supplement Date Received by Manufacturer: 10/16/2020
• Initial Report FDA Received Date: 07/17/2020
• Supplement Report FDA Received Date: 10/16/2020
• 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: Required Intervention