MAUDE Adverse Event Report: NORDSON MEDICAL FIBRIJET APPLICATOR TIP, SINGLE SPRAY; SYRINGE, IRRIGATING

Catalog Number SA-3671

Device Problems Entrapment of Device (1212); Device Inoperable (1663)

Patient Problem Pain (1994)

Event Date 10/05/2015

Event Type  malfunction  

Event Description

Patient had a left total knee replacement last fall.Subsequently, the patient complained of knee pain and that her knee was "locking up".Today, the patient had an arthroscopy of her knee.The arthroscopy was performed at another facility.Reportedly, it was discovered that the applicator tip of a fibrijet that was used during the total knee replacement surgery was retained in the patient's knee.It is our further understanding that the applicator tip was removed during the arthroscopy and is being retained by the other facility.

• Brand Name: FIBRIJET APPLICATOR TIP, SINGLE SPRAY
• Type of Device: SYRINGE, IRRIGATING
• Manufacturer (Section D): NORDSON MEDICAL; 805 w 71st st; loveland CO 80538
• MDR Report Key: 6016892
• MDR Text Key: 56970739
• Report Number: 6016892
• Device Sequence Number: 1
• Product Code: KYZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: SA-3671
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/08/2016
• Event Location: Hospital
• Date Report to Manufacturer: 09/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 85 YR