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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 05/15/2020
Event Type  malfunction  
Event Description
It was reported that, during a meniscus repair surgery, when the package was opened, the "meniscus mender ii disposable set" was found to be damaged, the device was disassembled between the shaft and the loop's head.The procedure was successfully completed without delay using a back-up device.No patient injuries or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
 
Manufacturer Narrative
H10, h3, h6: one disposable meniscus mender ii set used in treatment, was returned for evaluation.Instructions for use contains recommendations and precautionary statements for proper use of product.The allegation was observed.Policy is to return product as found.The snare loop wires were broken at the head to shaft weld.To avoid components from shifting within the package, individual component storage cradles are intentionally snug.The heads of the braided loop components snap into their packaging cavities.Use of the distal end (head) to remove snare loops from the tray may result in weakening, bending or complete fracture between at the head and shaft connection.Proper method of retrieval is to push and pop the head of the component from the back of the cradle.Complaint history review indicated similar allegations for the lot number reported.Batch review indicated no condition, product or procedure failure that supported the allegation.The condition was confirmed during further investigation by engineering.Engineering evaluation confirmed the product met specifications at the time of distribution.
 
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Brand Name
SET MENISCUS MENDER II DISPOSABLE
Type of Device
PASSER
Manufacturer (Section D)
SMITH & NEPHEW, INC.
130 forbes blvd.
mansfield MA 02048
MDR Report Key10136381
MDR Text Key194701676
Report Number1219602-2020-00874
Device Sequence Number1
Product Code HWQ
UDI-Device Identifier03596010468482
UDI-Public3596010468482
Combination Product (y/n)N
PMA/PMN Number
K885311
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 06/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/09/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number7209485
Device Lot Number2031439
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/23/2020
Date Manufacturer Received06/26/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age27 YR
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