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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SET,MENISCUS MENDER II DISPOSABLE PASSER

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SMITH & NEPHEW, INC. SET,MENISCUS MENDER II DISPOSABLE PASSER Back to Search Results
Catalog Number 7209485
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/21/2018
Event Type  malfunction  
Event Description
It was reported that during a meniscal suture, during the passing of the thread into the lasso, the loop at the end of the metallic lasso, came off into the patient knee. This lead to a change of material and search of the lost nozzle in the knee. The nozzle was retrieved. There was a loss of time.
 
Manufacturer Narrative
Visual inspection and functional testing could not be performed because the device in question has not been returned for evaluation. Thus, the complaint could not be verified and a root cause could not be determined with confidence. It is difficult to perform an accurate evaluation of a failure without having the failed product. As such the complaint is being closed without conclusion. However, if the product is returned in the future the complaint can be reopened and evaluated.
 
Manufacturer Narrative
One suture loop from a meniscus mender ii set was returned for evaluation. Visual assessment of the device confirmed the reported complaint. The braided loop has come free from the shaft. As part of continuous improvement, the manufacture of the suture loop has been moved to a new vendor for improved manufacturability. A change to the design specifications for the suture loop has also been implemented which will improve device quality. This device was manufactured prior to these changes.
 
Manufacturer Narrative
Visual inspection and functional testing could not be performed because the device in question has not been returned for evaluation. Thus, the complaint could not be verified and a root cause could not be determined with confidence. It is difficult to perform an accurate evaluation of a failure without having the failed product. As such the complaint is being closed without conclusion. However, if the product is returned in the future the complaint can be reopened and evaluated. Additional comment: this follow-up report is being submitted with information previously provided to you on (b)(4) 2019 and (b)(4) 2019 which is in our system marked as both failed emdr and duplicate emdr. As such, we cannot safely claim that fda has received all information intended and we are submitting the information once again.
 
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Brand NameSET,MENISCUS MENDER II DISPOSABLE
Type of DevicePASSER
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 Key8148388
MDR Text Key129897661
Report Number1219602-2018-01694
Device Sequence Number1
Product Code HWQ
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K885311
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup,Followup
Report Date 05/06/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/10/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number7209485
Device Lot Number50736314
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/22/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/03/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/17/2018
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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