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

Model Number 7209485

Device Problem Misassembled (1398)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/04/2020

Event Type  malfunction  

Event Description

It was reported that the set of meniscus mender the loop retrievers were already disassembled between head and shaft.The incident occurred before the procedure; no complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

One disposable meniscus mender ii set intended for use in treatment, was not returned for evaluation.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 correct method of retrieval is to push the head of the component from the back of the cradle which will pop it free.Complaint history review for three years prior indicated similar allegations for the product code reported.Batch review was unattainable without a valid lot number reported.Instructions for use contains recommendations and precautionary statements for proper use of product.The product family is under review.Engineering evaluation confirmed the product met specifications at the time of distribution.

• 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: 10473357
• MDR Text Key: 205006711
• Report Number: 1219602-2020-01334
• 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
• Report Date: 10/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2020
• 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: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1