MAUDE Adverse Event Report: BIOMET, INC. G7 DEPTH GAUGE; GAUGE, DEPTH

Model Number 110010717

Device Problems Break (1069); Unstable (1667)

Patient Problem No Code Available (3191)

Event Date 08/21/2018

Event Type  Injury  

Event Description

On (b)(6) 2018, the pt underwent a revision right hip arthroplasty for recurrent instability.After removal of the current implant and reaming, an acetabular shell was placed.The surgeon subsequently drilled and placed 2 screws superiorly through the cup.After drilling for a 3rd screw and measuring with a depth gauge, it was noted that the distal 1 cm of the depth gauge had broken off within the pelvis.An attempt was made to retrieve the distal cm of the depth gauge; however, this was not possible.At this point it was felt that further attempts or dissection in order to remove this piece would cause more harm than good and the decision was made to proceed forward with the surgery, and a screw was placed in that previously drilled screw path.

• Brand Name: G7 DEPTH GAUGE
• Type of Device: GAUGE, DEPTH
• Manufacturer (Section D): BIOMET, INC.
• MDR Report Key: 7859642
• MDR Text Key: 119799014
• Report Number: MW5079663
• Device Sequence Number: 1
• Product Code: HTJ
• 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: 09/05/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 110010717
• 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 Outcome(s): Other
• Patient Age: 69 YR
• Patient Weight: 66