MAUDE Adverse Event Report: SMITH & NEPHEW, INC. RETROGRADE DRL 10MM; BIT, SURGICAL

Model Number 72204046

Device Problem Break (1069)

Patient Problems No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/27/2020

Event Type  Injury  

Event Description

It was reported that during acl reconstruction, the acufex trunav retrograde drill, failed when attempting to drill through the lateral femoral cortex, spliting in two pieces, all pieces were removed using pickups and hemostat; the procedure was completed using a competitor device, no other complications or delay were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H3, h6: the reported device was received for evaluation.There was a relationship found between the device and the reported event.A complaint history review found similar reported events.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.The instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A visual inspection of the returned device found that it is not in its original packaging.The antegrade drill is broken away from the shaft.The retrograde drill was not returned.The actuator wire is broken at the distal end but still attached to the grey slider.There is debris on the device.A review of the customer provided image finds the complaint device, with the distal end fractured away on a surgical tray with other devices.The provided fluoroscopic image confirms the reported failure mode of the retrograde drill.Per the complaint details, all pieces were removed from the patient using pickups and a hemostat.The procedure was completed using a competitor¿s back-up device with less than 30 minutes delay.The patient impact beyond that which has already been reported cannot be determined.No further clinical assessment can be rendered at this time.Should any additional relevant clinical information be provided, this complaint would be re-assessed.The complaint was confirmed, and the root cause was associated with unintended use of the device.Factors that could have contributed to the reported event include an application of unintended inappropriate or excessive force to the device, attempted correction of a damaged device, or an impact event inconsistent with normal use.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.

• Brand Name: RETROGRADE DRL 10MM
• Type of Device: BIT, SURGICAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 10585948
• MDR Text Key: 208509456
• Report Number: 1219602-2020-01470
• Device Sequence Number: 1
• Product Code: GFG
• UDI-Device Identifier: 00885554037753
• UDI-Public: 00885554037753
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72204046
• Device Catalogue Number: 72204046
• Device Lot Number: 4905312
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention