MAUDE Adverse Event Report: ARTHREX MANUFACTURING INC. ARTHREX FIBULOCK ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Device Problems Break (1069); Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Date 11/11/2021

Event Type  Injury  

Event Description

Patient presented with a distal fibula fracture and associated syndesmosis disruption. Was initially treated with arthrex fibula nail aka fibulock and tightrope xp. Nail was broken within 12 days. To remove nail, large amounts of bone had to be removed and a large incision followed by a implanting a plate as a replacement treatment. Fda safety report id# (b)(4).

• Brand Name: ARTHREX FIBULOCK
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): ARTHREX MANUFACTURING INC.
• MDR Report Key: 12820556
• MDR Text Key: 280902831
• Report Number: MW5105349
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary

Reporter Occupation

• Type of Report: Initial
• Report Date: 11/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No

Patient Treatment Data

Date Received: 11/15/2021 Patient Sequence Number: 1