MAUDE Adverse Event Report: OMNILIFESCIENCE, INC. OMNI; BIT, DRILL

Model Number HS-6111

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

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

Event Date 01/22/2019

Event Type  malfunction  

Event Description

While drilling the pilot hole for the anterior screw, the drill bit broke off and was irretrievable.

• Brand Name: OMNI
• Type of Device: BIT, DRILL
• Manufacturer (Section D): OMNILIFESCIENCE, INC.; 480 paramount dr; raynham MA 02767
• MDR Report Key: 9202624
• MDR Text Key: 162656027
• Report Number: 9202624
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/30/2019,09/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: HS-6111
• Device Catalogue Number: HS-6111
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/30/2019
• Date Report to Manufacturer: 10/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1