MAUDE Adverse Event Report: STRYKER CORP. STRYKER SUPRACONDYLAR NAIL (SCN) SYSTEM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Date 12/14/2018

Event Type  malfunction  

Event Description

Patient with femoral shaft fracture had a stryker retrograde nail placed 6 weeks ago.Distal screw has backed out and is now prominent.It'll need to be removed next week assuming it doesn't erode through his skin first.This now makes 5 that we know about in the last 1.5 years.

• Brand Name: STRYKER SUPRACONDYLAR NAIL (SCN) SYSTEM
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER CORP.; 2825 airview blvd.; portage MI 49002
• MDR Report Key: 8260292
• MDR Text Key: 133523918
• Report Number: 8260292
• 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: 12/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/19/2018
• Event Location: Hospital
• Date Report to Manufacturer: 01/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 16790 DA