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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 Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/18/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that the device broke while using it. The procedure was successfully completed without delay using a back-up device. No patient injury or other complications were reported.
 
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. 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. No further investigation is required.
 
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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 
5123585706
MDR Report Key8503822
MDR Text Key141817736
Report Number1219602-2019-00420
Device Sequence Number1
Product Code HWQ
UDI-Device Identifier03596010468482
UDI-Public03596010468482
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K885311
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 05/08/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/11/2019
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number7209485
Device Lot Number50769342
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 Received05/07/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/11/2018
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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