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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 Material Separation (1562)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/23/2020
Event Type  malfunction  
Event Description
It was reported that during a meniscus repair surgery, but before use; the two loop retrievers of the "set meniscus mender ii" were already disassembled between head and shaft when the package was opened. Although it is unknown if backup device was available, there is no confirmation that reasonably suggests the procedure cancellation, a change in the surgical technique, nor the use of a competitor device occurred. However, the surgery was not delayed and no patient injuries or other complications were reported.
 
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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 Key10067967
MDR Text Key191377089
Report Number1219602-2020-00793
Device Sequence Number1
Product Code HWQ
UDI-Device Identifier03596010468482
UDI-Public3596010468482
Combination Product (y/n)N
Reporter Country CodeJA
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,Followup,Followup
Report Date 06/29/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/18/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number7209485
Device Lot Number2037273
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer06/17/2020
Is the Reporter a Health Professional? Yes
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 Manufactured07/22/2019
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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