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

Model Number 7209485

Device Problem Material Separation (1562)

Patient Problem No Patient Involvement (2645)

Event Date 06/04/2020

Event Type  malfunction  

Event Description

It was reported that the meniscus mender needles were damaged, the handle was broken.The incident occurred before the procedure; therefore, there was no patient involvement.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

One 7209485 disposable meniscus mender ii set used in treatment, was returned for evaluation.Instructions for use (ifu) contains recommendations and precautionary statements for proper use of product.Policy is to return product as found.The allegation was observed.Just the snare loop wires were returned with broken head to shaft welds, which is the cause of the failures.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.Engineering evaluation confirmed the product met specifications at the time of distribution.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.This resulted with initiation of a corrective action and potential process change.Root cause was addressed via surveillance and corrective action for the product family.The laser welding process validation has been completed and showed improvement, however it was decided that further improvements would be pursued.Corrective action has been updated to pursue additional actions related to design and/ or process changes, with a due date of october 2020.This is an ongoing action at this time.Allegation rate of occurrences continue to be monitored via surveillance.

• 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: 10279268
• MDR Text Key: 199072852
• Report Number: 1219602-2020-01036
• 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: 07/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2020
• 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: 2037273
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2020
• Date Manufacturer Received: 07/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1