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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. RAZORCUT 3.5MM EP-1 DISP BLD SAW, POWERED, AND ACCESSORIES

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SMITH & NEPHEW, INC. RAZORCUT 3.5MM EP-1 DISP BLD SAW, POWERED, AND ACCESSORIES Back to Search Results
Model Number 7205317
Device Problem Device Contaminated During Manufacture or Shipping (2969)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/31/2020
Event Type  malfunction  
Event Description
It was reported that during a procedure, the blade had a foreign matter of black color attached when the package was opened. There was no delay in the case. No patient injury or other complications were reported. It is unknown how the procedure was finished. All available information has been disclosed. If additional information should become available, a supplemental report will be submitted accordingly.
 
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Brand NameRAZORCUT 3.5MM EP-1 DISP BLD
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
w. william cannon drive 7000
5123913906
MDR Report Key10445902
MDR Text Key204196251
Report Number1219602-2020-01305
Device Sequence Number1
Product Code HAB
Combination Product (y/n)N
Reporter Country CodeJA
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 10/01/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/24/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number7205317
Device Catalogue Number7205317
Device Lot Number50827958
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/30/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/12/2019
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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