MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BURR 5.5MM ABRADER 180MML DISPOSABLE (3; SAW, POWERED, AND ACCESSORIES

Model Number 72200082

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Insufficient Information (4580)

Event Date 01/02/2021

Event Type  Injury  

Manufacturer Narrative

Dantas p, gonçalves s, mascarenhas v, camporese a, marin-peña o.Hip arthroscopy with initial access to the peripheral compartment provides significant improvement in fai patients.Knee surg sports traumatol arthrosc.2021 may;29(5):1453-1460.Doi: 10.1007/s00167-020-06380-z.Epub 2021 jan 2.Pmid: 33386879.(b)(4).

Event Description

It was reported that on literature review ¿hip arthroscopy with initial access to the peripheral compartment provides significant improvement in fai patients.¿; after surgery patient had revision for residual cam correction.Paper indicates that smith&nephew device was used, however no malfunction was reported during use.

Manufacturer Narrative

H3, h6: the reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.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.There was no way to determine if the device contributed to the reported event.A complaint history review found similar 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 review of risk management files found that the reported failure was documented appropriately.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: BURR 5.5MM ABRADER 180MML DISPOSABLE (3
• 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: 12436515
• MDR Text Key: 270268442
• Report Number: 1219602-2021-01884
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 03596010541529
• UDI-Public: 03596010541529
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 72200082
• Device Catalogue Number: 72200082
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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