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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TFCC MENDER DISPOSABLE SUTURE SYSTEM PASSER

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SMITH & NEPHEW, INC. TFCC MENDER DISPOSABLE SUTURE SYSTEM PASSER Back to Search Results
Model Number 7210752
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/24/2020
Event Type  malfunction  
Event Description
It was reported that during a meniscus repair, when the meniscus mender pack was opened, it was found that the two metals loops were broken off. The procedure was completed without delay using a back-up device. No patient injury or 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 NameTFCC MENDER DISPOSABLE SUTURE SYSTEM
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 Key10410952
MDR Text Key203104704
Report Number1219602-2020-01257
Device Sequence Number1
Product Code HWQ
Combination Product (y/n)N
Reporter Country CodeNZ
PMA/PMN Number
K885311
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/25/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/14/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number7210752
Device Catalogue Number7210752
Device Lot Number2041140
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/24/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/28/2019
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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