MAUDE Adverse Event Report: SMITH & NEPHEW, INC. RETROGRADE DRL 9MM; BIT, SURGICAL

Model Number 72204044

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/19/2023

Event Type  malfunction  

Event Description

It was reported that during an arthroscopy, the retrograde drill´s blade actuator wire broke, and a loud click sound, resulting in difficulty to retract the cutting blade while drilling the femur tunnel.All the broken pieces were successfully retrieved from the patient by artery and graspers.Non-significant delay was reported, and the procedure was finished with a smith and nephew back up device used in the originally drilled bone hole.No void was left in the patient.No further complications were reported.

Manufacturer Narrative

H10: internal complaint reference: (b)(4).

Manufacturer Narrative

H3, h6: the reported device was received for evaluation.A visual inspection revealed that the returned device was not in its original packaging.The device was returned with debris on the drills and in the shaft.The actuator wire was detached from the grey slider.A functional evaluation was performed on the returned device and found that it was unable to function as designed due to the actuator bar being detached from the grey slider.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found similar reported events.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.The root cause has been associated with unintended use of the device.Factors that could have contributed to the failure include excessive force during use, failure to retract the guidewire far enough back before attempting to deploy the blade, using the reverse function while drilling, attempting to deploy the blade while still inside the bone tunnel, or an impact event inconsistent with normal use.No containment or corrective actions are recommended at this time.

• Brand Name: RETROGRADE DRL 9MM
• 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: 16973402
• MDR Text Key: 315662361
• Report Number: 1219602-2023-00739
• Device Sequence Number: 1
• Product Code: GFG
• UDI-Device Identifier: 00885554037739
• UDI-Public: 00885554037739
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72204044
• Device Catalogue Number: 72204044
• Device Lot Number: 5436120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2022
• 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 Age: 26 YR
• Patient Sex: Male