MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SURGICAL DRILL BIT; BIT, DRILL

Patient Problem Unspecified Tissue Injury (4559)

Event Date 09/11/2023

Event Type  Injury  

Event Description

Patient to have total right knee arthroplasty.Surgeon attempted to drill bone, drill slipped and entered the popliteal space pulling out a portion of vein.Surgeon felt drill bit was dull.

• Brand Name: SURGICAL DRILL BIT
• Type of Device: BIT, DRILL
• Manufacturer (Section D): SMITH & NEPHEW, INC.
• MDR Report Key: 17818212
• MDR Text Key: 324354323
• Report Number: MW5146151
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2023
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female