MAUDE Adverse Event Report: ARTHREX, INC. ARTHREX LOW PROFILE LAPIDUS PLATE AR-8941; PLATE, FIXATION, BONE

Model Number AR-8941

Device Problems Break (1069); Unintended Movement (3026)

Patient Problem Failure of Implant (1924)

Event Date 03/12/2021

Event Type  Injury  

Event Description

Patient got a midfoot fusion by a different surgeon between 8-12 months ago.Fusion site did not fuse due to broken hardware causing too much motion.Plate was made by arthrex item 8941.Fda safety report id# (b)(4).

• Brand Name: ARTHREX LOW PROFILE LAPIDUS PLATE AR-8941
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.
• MDR Report Key: 11514958
• MDR Text Key: 241051997
• Report Number: MW5100084
• Device Sequence Number: 1
• Product Code: HRS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AR-8941
• Device Catalogue Number: AR-8941
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 63 YR
• Patient Weight: 58