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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
Catalog Number 4449
Device Problems Material Discolored (1170); Material Fragmentation (1261)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 01/15/2019
Event Type  malfunction  
Event Description
It was reported that during a carpal tunnel release procedure, the blade was emitting metallic colored resin after inserting in to defect and cutting tissue. There was resin left behind in the patient tissue. A backup device was available, but there was no need to used it. No revision surgery is planned due to the event. There was a delay of less than 29 minutes to identify the material. The devices involved were used on the same patient. No reported negative outcome to dates.
 
Manufacturer Narrative
One ectra retrograde knife returned. The complaint stated: ¿the blades would emit a metallic-colored resin after inserting in to defect and cutting tissue. ¿ the knife was evaluated and found to have a dry, fine, black substance on the surface of the blade. Primarily in the distal area. Evaluation was assigned to engineering. Initial review confirmed that substance was present. Samples were wiped onto paper and isolated to be sent out for lab analysis. Per engineering: ¿based on the detailed development of the safety limits, cleaning process validation, and operator training established for the manufacturing of ectra knives, the impact of the identified contaminant and its overall risk are deemed low. ¿ elements found were determined to be regarded as safe.
 
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Brand NameKNIFE ,RETROGRADE,BOXED SET
Type of DeviceARTHROSCOPE
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
jim gonzales
7000 west william cannon drive
austin, TX 78735
5123585706
MDR Report Key8308809
MDR Text Key135149606
Report Number1219602-2019-00147
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K954627
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 03/27/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/05/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number4449
Device Lot Number50681690
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/30/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/20/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/24/2017
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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