MAUDE Adverse Event Report: EXACTECH DRILL BIT

Model Number 321-20-00

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Failure of Implant (1924)

Event Date 07/28/2017

Event Type  Injury  

Event Description

Color-coded exactech drill bit broke off in the patient's glenoid process.Surgeon left the fragment in place and placed a locking screw cap over the top of the broken drill bit.Surgeon stated it would be unsafe to try to remove the fragment.

• Brand Name: DRILL BIT
• Type of Device: DRILL BIT
• Manufacturer (Section D): EXACTECH; gainesville FL 32653
• MDR Report Key: 6787596
• MDR Text Key: 82599406
• Report Number: MW5071514
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 08/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 321-20-00
• Was Device Available for Evaluation?: Yes
• 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 Age: 72 YR