MAUDE Adverse Event Report: ARTHREX BICEPS BUTTON; FASTENER, FIXATION, NONDEGRADABLE SOFT TISSUE

Device Problems Detachment Of Device Component (1104); Migration or Expulsion of Device (1395)

Patient Problems Pain (1994); Scarring (2061); Foreign Body In Patient (2687); No Code Available (3191)

Event Date 08/10/2017

Event Type  Injury  

Event Description

An arthrex "biceps button" has failed - becoming a loose foreign object in my arm.The metal button (which is titanium) then migrated into my shoulder joint causing shoulder damage and extensive pain.The loose metal object required surgical removal which has left me with several scars and significant out of pocket medical costs.I believe the use of this product in its current form should be discontinued.As the product (the biceps button) can come loose and move inside the body, it should only be made of a bioabsorbable material.This product needs to be redesigned to reflect the risk of coming loose and moving throughout the body over the course of a human lifetime.

• Brand Name: BICEPS BUTTON
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE SOFT TISSUE
• Manufacturer (Section D): ARTHREX
• MDR Report Key: 6794049
• MDR Text Key: 82790894
• Report Number: MW5071566
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability
• Patient Age: 46 YR
• Patient Weight: 79