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

Model Number 72204041

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 03/04/2021

Event Type  malfunction  

Event Description

A smith and nephew non implantable product broke inside a patient during a routine right anterior cruciate ligament (acl) repair with autograft.Product was acufex trunav retrograde drill, 7.5mm.The device and pieces were successfully retrieved from the patient and compared to identical product for confirmation between surgeon, nurse and tech.

• Brand Name: ACUFEX
• Type of Device: BIT, SURGICAL
• Manufacturer (Section D): SMITH NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 11723451
• MDR Text Key: 247287910
• Report Number: 11723451
• Device Sequence Number: 1
• Product Code: GFG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/20/2021

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: Health Professional
• Device Model Number: 72204041
• Device Catalogue Number: 72204041
• Device Lot Number: 5045355
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/20/2021
• Event Location: Hospital
• Date Report to Manufacturer: 04/26/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 5475 DA
• Patient Weight: 65