MAUDE Adverse Event Report: ARTHREX MANUFACTURING, INC. ARTHREX DOGBONE; WASHER, BOLT NUT

Model Number AR-2270

Device Problems Device Dislodged or Dislocated (2923); Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Date 07/15/2020

Event Type  Injury  

Event Description

Patient had and ac separation that was initially treated with the arthrex dog bone implant.A few weeks later, the anchor in the corocoid had pulled out and was revised using a clavicle hook plate.Fda safety report id # (b)(4).

• Brand Name: ARTHREX DOGBONE
• Type of Device: WASHER, BOLT NUT
• Manufacturer (Section D): ARTHREX MANUFACTURING, INC.
• MDR Report Key: 11273063
• MDR Text Key: 230555693
• Report Number: MW5099186
• Device Sequence Number: 1
• Product Code: HTN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 01/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AR-2270
• Device Catalogue Number: AR-2270
• Was Device Available for Evaluation?: 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): Hospitalization; Other; Required Intervention
• Patient Age: 36 YR