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

Model Number 72204045

Device Problem Break (1069)

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

Event Date 01/23/2022

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference#: (b)(4).

Event Description

It was reported that during a knee arthroscopy procedure, the (b)(6) blade inside the retrograde drill could not be closed, it was stuck.The metal piece broke inside the knee and the piece was retrieved with a grasper.The procedure was successfully completed with non-significant delay using a back-up device.No patient complications were reported.

Manufacturer Narrative

H3, h6: the reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.There was no way to determine if the device contributed to the reported event.A complaint history review concluded this was a repeat issue.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 was documented appropriately, and there were no indications to suggest that the anticipated risk region is not adequate.Per case details, the broken metal piece was retrieved from the patient.The procedure was completed using a back-up device.No patient injuries or adverse consequences were reported.Since no patient injuries are being reported no further clinical/medical assessment is warranted at this time.The complaint was not confirmed.Factors that could have contributed to the reported event 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.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.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.

• Brand Name: RETROGRADE DRL 9.5MM
• 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: 13518184
• MDR Text Key: 285853087
• Report Number: 1219602-2022-00202
• Device Sequence Number: 1
• Product Code: GFG
• UDI-Device Identifier: 00885554037746
• UDI-Public: 00885554037746
• 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,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2023
• Device Model Number: 72204045
• Device Catalogue Number: 72204045
• Device Lot Number: 4954697
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2022
• Date Device Manufactured: 01/14/2020
• 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): Other
• Patient Sex: Male
• Patient Weight: 60 KG