MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SET MENISCUS MENDER II DISPOSABLE; PASSER

Model Number 7209485

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/09/2020

Event Type  malfunction  

Event Description

It was reported that the needle of the meniscus mender was broken.Incident occurred before a meniscal repair procedure.There was a delay of 0-30 and min and there was a back-up device available.

Manufacturer Narrative

H3, h6: one 7209485 disposable meniscus mender ii set was returned for evaluation.Visual assessment confirmed the complaint.The loop meniscal were broken from the bottom.To avoid components from shifting within the package, individual component storage cradles are intentionally snug.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 did not indicate a condition, product or procedure failure that supported the allegation although the condition was confirmed during further investigation by engineering.Engineering evaluation confirmed the product met specifications at the time of distribution.Further investigation is not warranted at this time.

Manufacturer Narrative

One 7209485 disposable meniscus mender ii set used for treatment, was not returned for evaluation.Due to product unavailability, the complaint could not be ultimately confirmed.Definitive conclusions, accurate investigation and evaluation were limited without evaluation of physical product.Factors that may affect device performance include: device ability, surgical ability, procedure location and tissue condition.The instruction for use (ifu 1061202) states, ¿prior to use, inspect the device to ensure it is not damaged.Do not use a damaged device.¿ to keep components from shifting within the package, the product storage cradles are intentionally snug.The heads of the braided loop components snap into their packaging cavities to avoid inadvertent loop disturbance during removal from their cradles.Removal of a loop from the tray using the distal end (head) can result in weakening, bending or complete fracture between the head and shaft.The most successful method of retrieval is to push the head of the component from the back of the cradle which will pop it free.Recent engineering evaluation confirmed this product met specifications upon release.The product family is under review.Occurrence rate of allegations are monitored via surveillance.In response, engineering action was initiated.

• 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 Key: 10343541
• MDR Text Key: 200999818
• Report Number: 1219602-2020-01157
• Device Sequence Number: 1
• Product Code: HWQ
• UDI-Device Identifier: 03596010468482
• UDI-Public: 03596010468482
• Combination Product (y/n): N
• PMA/PMN Number: K885311
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 09/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7209485
• Device Catalogue Number: 7209485
• Device Lot Number: 2034277
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2020
• Date Manufacturer Received: 09/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1