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 03/12/2021

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that during the surgery, when the meniscus mender package was being opened it was notice that the device was broken.Smith and nephew back-up device was available to complete the surgery.No other complications or significant delay reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H10, h3,h6: the reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.There was a relationship found between the subject device and the reported incident.An analysis of the customer provided image revealed that one of the meniscal suture loops in the set had detached from the handle.This often occurs when they are removed from the packaging by pulling the device instead of pushing out the handle from behind the package.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: 11618918
• MDR Text Key: 243928739
• Report Number: 1219602-2021-00775
• 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: 05/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2021
• 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: 2033453
• Date Manufacturer Received: 05/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1