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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 04/15/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that during surgery, the loop retriever of the meniscus mender was disassembled between the head an the shaft when it was removed from the package. It was not reported if there were any delays in a surgical procedure. The procedure was successfully completed 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 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 Key10029215
MDR Text Key190015334
Report Number1219602-2020-00738
Device Sequence Number1
Product Code HWQ
UDI-Device Identifier03596010468482
UDI-Public03596010468482
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
Report Date 06/19/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/06/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number7209485
Device Catalogue Number7209485
Device Lot NumberUNKNOWN
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 Received06/18/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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