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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
Model Number 7209485
Device Problem Material Separation (1562)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/18/2020
Event Type  malfunction  
Event Description
It was reported that during meniscus repair surgery, when the set meniscus mender ii disposable was opened, it was found product damaged, both loops were broken. A backup device was available to complete the procedure with no patient injuries. Surgical delay greater than 30 minutes was 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 NameSET MENISCUS MENDER II DISPOSABLE
Type of DevicePASSER
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 Key10138836
MDR Text Key194668446
Report Number1219602-2020-00878
Device Sequence Number1
Product Code HWQ
Combination Product (y/n)N
Reporter Country CodeCH
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 06/25/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/10/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number7209485
Device Catalogue Number7209485
Device Lot Number2031439
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/11/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/24/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/22/2019
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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