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

Model Number 7209485

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/19/2021

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that, during set up or inspection for a meniscus procedure, the meniscus mender broke off on the base of the silver piece that connects with the needle.The procedure was completed with a s+n back up device.No delay and no patient complications were reported.

Manufacturer Narrative

Internal complaint reference (b)(4).H3, h6: the reported device, intended for use in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A complaint history review concluded this was an isolated event.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A relationship, if any, between the subject device and the reported event could not be determined.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.

• Brand Name: SET MENISCUS MENDER II DISPOSABLE
• Type of Device: PASSER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12775120
• MDR Text Key: 280514232
• Report Number: 1219602-2021-02461
• Device Sequence Number: 1
• Product Code: HWQ
• UDI-Device Identifier: 03596010468482
• UDI-Public: 03596010468482
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K885311
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2021
• 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: 2075510
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1