MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. DEPUY DRILL BIT ; BIT, DRILL

Model Number 25MM DEPUY DRILL BIT

Device Problem Break (1069)

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

Event Type  No Answer Provided  

Event Description

Physician was performing a total hip arthroplasty.While using the 25mm depuy drill bit in the acetabulum, the drill bit broke.All the pieces were retrieved and an x-ray was taken at the end of the case to confirm there was no metal retained in the wound.Fda safety report id# (b)(4).

• Brand Name: DEPUY DRILL BIT
• Type of Device: BIT, DRILL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.
• MDR Report Key: 9744881
• MDR Text Key: 180857678
• Report Number: MW5093220
• 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: Other
• Type of Report: Initial
• Report Date: 02/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 25MM DEPUY DRILL BIT
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1