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

Model Number 7209485

Device Problem Nonstandard Device (1420)

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

Event Date 07/30/2020

Event Type  malfunction  

Event Description

It was reported that during the procedure, the loop retriever was already disassembled between head and shaft when the package was opened.No patient injury, delay 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

H3, h6: the reported device, used in treatment, was returned for evaluation.There was a relationship found between the returned device and the reported incident a visual inspection confirmed that the meniscal loop was broken from the handle.Use of the distal end to remove loops from the tray may result in weakening, bending or complete fracture between at the head and shaft connection.A review of the device records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was a repeat issue.The complaint was confirmed and the root cause was associated with device design.Corrective actions have been implemented.

• 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: 10463171
• MDR Text Key: 204698889
• Report Number: 1219602-2020-01328
• 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: 04/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2020
• Initial Date Manufacturer Received: 07/31/2020
• Initial Date FDA Received: 08/27/2020
• Supplement Dates Manufacturer Received: 04/08/2021
• Supplement Dates FDA Received: 04/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1