MAUDE Adverse Event Report: CROSSTEX INTERNATIONAL, INC. CROSSTEX TYVEK INTRAARTICULAR DEVICE WRAP STERIZATION

Model Number TSP-185

Device Problem Crack (1135)

Patient Problem No Code Available (3191)

Event Date 01/23/2020

Event Type  malfunction  

Event Description

Pt was undergoing a left total knee replacement and while placing the intraarticular device it cracked into several pieces. The wound was inspected and irrigated and area was x-rayed. X-ray was negative and procedure continued without further issues. Zimmer biomet, (b)(4). Fda safety report id# (b)(4).

• Brand Name: CROSSTEX TYVEK INTRAARTICULAR DEVICE
• Type of Device: WRAP STERIZATION
• Manufacturer (Section D): CROSSTEX INTERNATIONAL, INC.
• MDR Report Key: 9653637
• MDR Text Key: 177584819
• Report Number: MW5092658
• Device Sequence Number: 1
• Product Code: FRG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: TSP-185
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information

Was Device Evaluated by Manufacturer?

Is the Device Single Use?

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage

Patient Treatment Data

Date Received: 01/30/2020 Patient Sequence Number: 1