MAUDE Adverse Event Report: EXACTECH, INC.; REAMER

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Injury (2348)

Event Date 04/05/2019

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

Surgeon was reaming, and he caught the patient's glenoid.It was a small patient and he did not have a lot to work with.

Manufacturer Narrative

The following sections have updated info : (g4) date received by manufacturer: (b)(6) 2019.

Manufacturer Narrative

The event reported was likely the result of the surgeon coming in contact with the retractor while still powering the reamer and grabbing a piece of the anterior glenoid, which led to fracturing of the glenoid bone.

• Type of Device: REAMER
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 8513858
• MDR Text Key: 141917328
• Report Number: 1038671-2019-00240
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 08/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention