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 07/08/2021

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that during use in an unknown procedure, a loop retriever of the meniscus mender was disassembled between head and shaft when the package was opened.The procedure was successfully completed without delay using a smith and nephew back up device.No patient injury or other complications were reported.

Manufacturer Narrative

Health effect impact code updated.The reported device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A complaint history review concluded this was a repeat issue.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.Visual inspection found that the device was returned outside of it's original packaging.Two curved needles, one straight needle, and two suture loops were returned in the package.The returned straight needle has debris throughout.One of the suture loops is separated from the hub and there is debris on the shaft.The complaint was confirmed and the root cause was associated with device design.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.A corrective action for this failure mode is in place.

• 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: 12359958
• MDR Text Key: 267879480
• Report Number: 1219602-2021-01774
• 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,consum
• Type of Report: Initial,Followup
• Report Date: 09/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2021
• 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: 2065162
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2021
• Date Manufacturer Received: 09/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1