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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FULL RADIUS BLADE,3.5MM,DISP SAW, POWERED, AND ACCESSORIES

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SMITH & NEPHEW, INC. FULL RADIUS BLADE,3.5MM,DISP SAW, POWERED, AND ACCESSORIES Back to Search Results
Catalog Number 7205305
Device Problem Corroded (1131)
Patient Problem Foreign Body In Patient (2687)
Event Date 06/06/2019
Event Type  malfunction  
Event Description
It was reported that during an acl reconstruction surgery, the planer has rust spots and cannot be used. Additional information was received and was confirmed that the device was used in the patient. No patient injury or significant delay were reported. Back up device was available.
 
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Brand NameFULL RADIUS BLADE,3.5MM,DISP
Type of DeviceSAW, POWERED, AND ACCESSORIES
Manufacturer (Section D)
SMITH & NEPHEW, INC.
130 forbes boulevard
mansfield MA 02048
Manufacturer (Section G)
SMITH & NEPHEW, INC.
130 forbes boulevard
mansfield MA 02048
Manufacturer Contact
holly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key8746541
MDR Text Key149635431
Report Number1219602-2019-00756
Device Sequence Number1
Product Code HAB
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/22/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/28/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number7205305
Device Lot Number50758985
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/08/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/19/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/15/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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