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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INCISOR BLADE 3.5MM DSPL EP-1 SAW, POWERED, AND ACCESSORIES
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SMITH & NEPHEW, INC. INCISOR BLADE 3.5MM DSPL EP-1 SAW, POWERED, AND ACCESSORIES Back to Search Results
Model Number 7205312
Device Problem Detachment of Device or Device Component (2907)
Patient Problem Injury (2348)
Event Date 06/12/2020
Event Type  Injury  
Event Description

It was reported that, during a knee surgery, the tip of the "3. 5mm incisor blade" came off inside the patient. In consequence, the piece was removed from the patient. The procedure was successfully completed without delay using the same device. No other complications were reported. All available information has been disclosed. If additional information should become available, a supplemental report will be submitted accordingly.

 
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Brand NameINCISOR BLADE 3.5MM DSPL EP-1
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 Key10251818
MDR Text Key198148114
Report Number1219602-2020-01000
Device Sequence Number1
Product Code HAB
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 08/18/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/09/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number7205312
Device Catalogue Number7205312
Device LOT Number50840658
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 Received08/14/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/19/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 07/09/2020 Patient Sequence Number: 1
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