MAUDE Adverse Event Report: ARTHREX, INC. ARTHREX EXCALIBUR, 5.0MM X 13CM; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Model Number AR-8500EX

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/13/2020

Event Type  malfunction  

Event Description

Surgeon was using a 5.0mm arthrex shaver (ar-8500ex, lot 10453589, exp.: 10/31/2024) and the end of the shaver broke off.Surgeon aware, xray notified and surgeon retriever, foreign body under fluoroscopy.Type of surgery: right acl reconstruction.A disposable shaver blade was being used during a knee arthroscopy.While in use, a section of the shaver's outer sheath broke off and was discovered while surgeon was closing the subcutaneous tissue.The surgeon was able to retrieve the section in its entirety after it was viewed under fluoroscopy.The first layer of subcutaneous tissue had been closed at this point and had to be reopened and the sheath fragment removed.The patient was still under anesthesia at this time.The subcutaneous tissue and skin layers were closed by the surgeon without further incident.

• Brand Name: ARTHREX EXCALIBUR, 5.0MM X 13CM
• Type of Device: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside blvd; naples FL 34108
• MDR Report Key: 11990885
• MDR Text Key: 255940080
• Report Number: 11990885
• Device Sequence Number: 1
• Product Code: GFA
• 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: 06/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: AR-8500EX
• Device Catalogue Number: AR-8500EX
• Device Lot Number: 10453589
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/04/2021
• Event Location: Hospital
• Date Report to Manufacturer: 06/14/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 8760 DA