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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DYONICS 5.5MM ELITE STONECUTTER BURR SAW, POWERED, AND ACCESSORIES

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SMITH & NEPHEW, INC. DYONICS 5.5MM ELITE STONECUTTER BURR SAW, POWERED, AND ACCESSORIES Back to Search Results
Model Number 72200729
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Insufficient Information (4580)
Event Date 06/28/2021
Event Type  Injury  
Manufacturer Narrative
Internal complaint reference: (b)(4). Article: douiri, a. , lavoué, v. , galvin, j. , boileau, p. , & trojani, c. (2021). Arthroscopic lateral patellar facetectomy and lateral release can be recommended for isolated patellofemoral osteoarthritis. Arthroscopy: the journal of arthroscopic & related surgery.
 
Event Description
It was reported that on literature review ¿arthroscopic lateral patellar facetectomy and lateral release can be recommended for isolated patellofemoral osteoarthritis. ¿, after surgery with a dyonics 5. 5 mm elite stonecutter burr, six patients had revision surgery requiring a total knee replacement. No further information is available.
 
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Brand NameDYONICS 5.5MM ELITE STONECUTTER BURR
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 Key12426603
MDR Text Key270157760
Report Number1219602-2021-01855
Device Sequence Number1
Product Code HAB
Combination Product (y/n)N
Reporter Country CodeFR
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 09/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/05/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number72200729
Device Catalogue Number72200729
Device Lot NumberUNKNOWN
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: 09/05/2021 Patient Sequence Number: 1
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