MAUDE Adverse Event Report: ARTHREX, INC. EXCALIBUR, 4.0MM X 13CM; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Model Number EXCALIBUR, 4.0MM X 13CM

Device Problem Difficult to Remove (1528)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/14/2019

Event Type  Injury  

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.

Event Description

It was reported that during an arthroscopic rotator cuff repair, an excalibur, ar-8400ex, was used.When the surgeon tried to remove soft tissue, excalibur produced metal shavings inside of the joint.Most of the shavings were able to be removed via perfusion pump but, not all.The surgery was completed by using a competitor's product.Additional information provided 8/16/2019: the shavings were very small and powdery.The dualwave outflow tubing was used in the case and there was an uninterrupted flow of irrigation through the device during its use.

Manufacturer Narrative

Complaint confirmed.Visual evaluation revealed the presence of horizontal grooves within the inner diameter of the outer tube window, and consistent with a site of metal debris production.This event is consistent with user applied mechanical force via prying/leveraging, as further evidenced by the presence of scuffing along the shrink tubing at the proximal end of the device.

• Brand Name: EXCALIBUR, 4.0MM X 13CM
• Type of Device: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8960992
• MDR Text Key: 158978395
• Report Number: 1220246-2019-01290
• Device Sequence Number: 1
• Product Code: GFA
• UDI-Device Identifier: 00888867043589
• UDI-Public: 00888867043589
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2024
• Device Model Number: EXCALIBUR, 4.0MM X 13CM
• Device Catalogue Number: AR-8400EX
• Device Lot Number: 10305693
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other