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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 4.5MM INCISOR PLUS PLATINUM BLADE SAW, POWERED, AND ACCESSORIES

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SMITH & NEPHEW, INC. 4.5MM INCISOR PLUS PLATINUM BLADE SAW, POWERED, AND ACCESSORIES Back to Search Results
Model Number 72203013
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/21/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that during a knee surgery, internal to the patient, there was black grease inside the platinum blade. The procedure was completed without significant delay using the same device. No patient injury or other complications were reported.
 
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Brand Name4.5MM INCISOR PLUS PLATINUM BLADE
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 Key11817289
MDR Text Key250367852
Report Number1219602-2021-01112
Device Sequence Number1
Product Code HAB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/13/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number72203013
Device Catalogue Number72203013
Device Lot Number50909761
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/28/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/11/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/05/2020
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: 05/13/2021 Patient Sequence Number: 1
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