MAUDE Adverse Event Report: EXACTECH, INC. EXACTECH GLENOID REAMER

Model Number 321-25-38

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/31/2020

Event Type  Injury  

Event Description

Tip of glenoid reamer broke off into glenoid.Fda safety report id # (b)(4).

• Brand Name: EXACTECH GLENOID REAMER
• Type of Device: REAMER
• Manufacturer (Section D): EXACTECH, INC.; gainsville FL 32653
• MDR Report Key: 9769847
• MDR Text Key: 181631674
• Report Number: MW5093366
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 321-25-38
• Device Catalogue Number: 321-25-38
• Device Lot Number: N/A
• 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): Required Intervention
• Patient Age: 78 YR