MAUDE Adverse Event Report: ARTHREX, INC.; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

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

Patient Problems Pain (1994); Osteolysis (2377); Swelling/ Edema (4577)

Event Date 02/26/2021

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 a patient had a sl recon done in early (b)(6) 2020.The patient came back in (b)(6) 2021 with a lot of pain and swelling.The surgeon initially thought it was an infection, but all tests came back negative for infection.The surgeon performed a revision surgery to debride the scaphoid and lunate at what they described as "osteolysis of the bones, like the bones just melted away.The issue is around the 3.5 swivelock anchors as well." after the debridement, the surgeon scheduled a wrist fusion.

• Brand Name: UNK
• Type of Device: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 11544422
• MDR Text Key: 242382795
• Report Number: 1220246-2021-02762
• Device Sequence Number: 1
• Product Code: MAI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191226
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 03/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/02/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other