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

Model Number PS11.5-80SJ265

Device Problem Material Discolored (1170)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The device evaluation is in progress; upon completion, a follow-up medwatch will be submitted.

Event Description

It was reported that upon removal of the nail after it had achieved its intended purpose and outcome, it was noted that there were changes to the metal on the distal screw hole at the junction of the nail.No patient impact or adverse event was reported.

Event Description

No additional event information was provided.

Manufacturer Narrative

Additional data: d8, h3, h6, h10.Correction: d4.Device records review: a review of dhr for the returned unit confirmed that it met all the required quality inspection criteria prior to release.Device evaluation: visual inspection of the returned nail revealed that the distraction rod of the nail had corrosion.The root cause cannot be determined at this time; further investigation is being conducted through the capa process.

• Brand Name: PRECICE STRYDE SYSTEM
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise dr, suite 100; aliso viejo CA 92656
• MDR Report Key: 11499537
• MDR Text Key: 240622200
• Report Number: 3006179046-2021-00201
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 00887517951670
• UDI-Public: 887517951670
• Combination Product (y/n): N
• PMA/PMN Number: K180503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PS11.5-80SJ265
• Device Lot Number: 9022548AAA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1