MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ABRADER 2.9 MAG-MINI DISP. BLADE; SAW, POWERED, AND ACCESSORIES

Model Number 72201518

Device Problem Break (1069)

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

Event Date 03/03/2022

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference case-(b)(4).

Event Description

It was reported that during an arthroscopy procedure, the inner blade of the abrader burr, broke.The broken pieces were removed from the patient.The procedure was completed with a 10 minutes delay using a back-up device.No patient complications were reported.

Manufacturer Narrative

H10: 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.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review found similar reported events.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 the anticipated risk is not adequate.Per the subsequent e-mail, both devices failed in the same way involving only one patient.Although the details of the failure we not provided, it was reported, all the broken pieces were removed from the patient and the procedure was completed with a 10-minute delay using a back-up device.Since there was no alleged harm nor patient complications were reported, no further clinical/medical assessment is warranted at this time.There was no relationship found between the device and the reported event.The complaint was not confirmed.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: ABRADER 2.9 MAG-MINI DISP. BLADE
• Type of Device: SAW, POWERED, AND ACCESSORIES
• 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: 13925558
• MDR Text Key: 288016500
• Report Number: 1219602-2022-00449
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 03596010621672
• UDI-Public: 03596010621672
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 08/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72201518
• Device Catalogue Number: 72201518
• Device Lot Number: 50951613
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/19/2022
• Date Device Manufactured: 07/06/2021
• 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