MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SMITH AND NEPHEW 2.4 MM TWIST DRILL; BIT, DRILL

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/20/2023

Event Type  Injury  

Event Description

During robotic hip replacement surgery, drill bit broke and remained in femur (surgeon decision)."210".

• Brand Name: SMITH AND NEPHEW 2.4 MM TWIST DRILL
• Type of Device: BIT, DRILL
• Manufacturer (Section D): SMITH & NEPHEW, INC.
• MDR Report Key: 18311419
• MDR Text Key: 330378414
• Report Number: MW5149123
• 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: 12/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability