MAUDE Adverse Event Report: SMITH & NEPHEW, INC. RETROGRADE DRL 9.5MM; BIT, SURGICAL

Catalog Number 72204045

Device Problem Activation Problem (4042)

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

Event Date 05/10/2019

Event Type  malfunction  

Event Description

It was reported that during an acl reconstruction operation in or, trunav drill actuator failed proximally when the surgeon tried to actuate the cutter.This failure occurred due to buildup of bone debris around the cutter during antegrade drilling of femoral tunnel.The surgeon tried to clear the bone debris being stocked around the cutter by flossing action using trunav guidewire, but it did not work and consequently the actuator failed to deploy the cutter.A second trunav drill was used to finish retrograde drilling and the operation was completed successfully.No delay or patient injuries were reported.

Manufacturer Narrative

Further review of this event performed on (b)(6) 2019, has identified that the complaint description mentions a situation where the driller was clogged with bone debris and procedure was completed successfully with a backup device with no patient harm.This event was re-evaluated for mdr reporting.The reassessment determined that, based on the event information, the issue does not meet the threshold for reporting and is a non-reportable event.This report was made based upon information which smith & nephew had not been able to investigate or verify prior to the required reporting date.

• Brand Name: RETROGRADE DRL 9.5MM
• Type of Device: BIT, SURGICAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8635726
• MDR Text Key: 146226374
• Report Number: 1219602-2019-00593
• Device Sequence Number: 1
• Product Code: GFG
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/25/2024
• Device Catalogue Number: 72204045
• Device Lot Number: 4726281
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2019
• Date Manufacturer Received: 07/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1