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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OUTSIDE-IN MEDICAL REPAIR SYSTEM, MENISCUS MENDER II PASSER

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SMITH & NEPHEW, INC. OUTSIDE-IN MEDICAL REPAIR SYSTEM, MENISCUS MENDER II PASSER Back to Search Results
Model Number 7209485
Device Problems Break (1069); Detachment of Device or Device Component (2907)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/03/2019
Event Type  malfunction  
Event Description
The handle of the snare within the smith & nephew meniscus mender ii (ref# 7209485) is breaking off from the stem of the snare when removing from the sterile packaging prior to use. Fda safety report id # (b)(4).
 
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Brand NameOUTSIDE-IN MEDICAL REPAIR SYSTEM, MENISCUS MENDER II
Type of DevicePASSER
Manufacturer (Section D)
SMITH & NEPHEW, INC.
andover MA 01810
MDR Report Key9426220
MDR Text Key169857729
Report NumberMW5091496
Device Sequence Number1
Product Code HWQ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 12/03/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/05/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number7209485
Device Catalogue Number7209485
Device Lot Number2034277
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/03/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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