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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 Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/27/2021
Event Type  malfunction  
Manufacturer Narrative
Internal complaint reference case (b)(4).
 
Event Description
It was reported that during an unknown procedure, a loop retriever of the meniscus mender, was disassembled between head and shaft when opening the package. The procedure was completed without delay using the same device. No patient injury 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 Key12340606
MDR Text Key267227395
Report Number1219602-2021-01752
Device Sequence Number1
Product Code HWQ
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 09/21/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/19/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number7209485
Device Catalogue Number7209485
Device Lot Number2057162
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/13/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/20/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/19/2020
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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