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

Model Number PS10.0-80D335

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem Insufficient Information (4580)

Event Date 06/03/2020

Event Type  malfunction  

Event Description

During procedure to remove hardware from patient's femur, the intramedullary (im) rod broke and the rod could not be removed.Tip of nail broke during the procedure of trying to remove.

• Brand Name: PRECICE STRYDE SYSTEM
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise ste 100; aliso viejo CA 92656
• MDR Report Key: 12057658
• MDR Text Key: 258126813
• Report Number: 12057658
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/15/2021

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
• Device Operator: Other
• Device Model Number: PS10.0-80D335
• Device Catalogue Number: PS10.0-80D335
• Device Lot Number: 9060608
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/15/2021
• Event Location: Hospital
• Date Report to Manufacturer: 06/24/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/24/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 6935 DA