MAUDE Adverse Event Report: ARTHREX INC ARTHREX CLAVICLE PLATE; PLATE, FIXATION, BONE

Model Number AR-2655CL

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Failure of Implant (1924); Non-union Bone Fracture (2369)

Event Date 01/27/2021

Event Type  Injury  

Event Description

Patient had a clavicle fracture that was fixed in (b)(6) 2020 with an arthrex clavicle plate ar-2655 and 3.5mm cortex screws x6.Most of the screws backed out and resulted in a non union and had to be removed on (b)(6) 2021.The patient was compliant and otherwise healthy.Fda safety report id # (b)(4).

• Brand Name: ARTHREX CLAVICLE PLATE
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX INC
• MDR Report Key: 11260731
• MDR Text Key: 230140436
• Report Number: MW5099112
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 01/27/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: AR-2655CL
• Device Catalogue Number: AR-2655CL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• 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
• Patient Age: 46 YR