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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. KNIFE RETROGRADE BOXED SET ARTHROSCOPE

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SMITH & NEPHEW, INC. KNIFE RETROGRADE BOXED SET ARTHROSCOPE Back to Search Results
Model Number 4449
Device Problem Break (1069)
Patient Problem Insufficient Information (4580)
Event Date 12/21/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported a clean breakage of the knife retrograde boxed set when used in the operating room. It is unknown whether there was a back up available or delay in the case. 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 NameKNIFE RETROGRADE BOXED SET
Type of DeviceARTHROSCOPE
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 Key11164649
MDR Text Key226628968
Report Number1219602-2021-00119
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K954627
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 03/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/13/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number4449
Device Catalogue Number4449
Device Lot Number50876027
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/23/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/30/2020
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: 01/13/2021 Patient Sequence Number: 1
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