MAUDE Adverse Event Report: STRYKER STRYKER; CROSSFIRE 2

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Skin Erosion (2075)

Event Date 07/27/2017

Event Type  Injury  

Event Description

Reported a small linear area along the medial and distal aspects of knee with mild skin breakdown that extends to about the proximal and midportion of calf following dressing removal post-arthroscopy.Skin breakdown not evident upon bandaging in immediate post-op period.It has not been confirmed, but suspected hot irrigant from shaver traveled behind the knee under dressing during procedure.Bovie tower was checked upon notification, working properly.

• Brand Name: STRYKER
• Type of Device: CROSSFIRE 2
• Manufacturer (Section D): STRYKER
• MDR Report Key: 7078921
• MDR Text Key: 93724150
• Report Number: MW5073705
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• 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: 51 YR
• Patient Weight: 90