MAUDE Adverse Event Report: G SOURCE, LLC G-SOURCE DRILL BIT; BIT, DRILL

Model Number G SOURCE 86.84.20 SIZE 2.0

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

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

Event Type  malfunction  

Event Description

Physician was performing a right total hip arthroplasty.While drilling in the trochanter, a portion of the 2.0 drill bit broke off in the pt.Fda safety report id# (b)(4).

• Brand Name: G-SOURCE DRILL BIT
• Type of Device: BIT, DRILL
• Manufacturer (Section D): G SOURCE, LLC
• MDR Report Key: 9539121
• MDR Text Key: 173513072
• Report Number: MW5091969
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 12/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: G SOURCE 86.84.20 SIZE 2.0
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/31/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1