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U.S. Department of Health and Human Services

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

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SMITH & NEPHEW, INC. BURR 5.5MM ABRADER 180MML DISPOSABLE (3 SAW, POWERED, AND ACCESSORIES Back to Search Results
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.
 
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Brand NameBURR 5.5MM ABRADER 180MML DISPOSABLE (3
Type of DeviceSAW, 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 Key12436515
MDR Text Key270268442
Report Number1219602-2021-01884
Device Sequence Number1
Product Code HAB
Combination Product (y/n)N
Reporter Country CodePO
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation
Type of Report Initial
Report Date 09/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/07/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number72200082
Device Catalogue Number72200082
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/16/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/07/2021 Patient Sequence Number: 1
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