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

Model Number 7209485

Device Problem Material Separation (1562)

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

Event Date 04/15/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that during surgery, the loop retriever of the meniscus mender was disassembled between the head an the shaft when it was removed from the package.It was not reported if there were any delays in a surgical procedure.The procedure was successfully completed using a back-up device.No patient injury 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: one 7209485 disposable meniscus mender ii set used for treatment but was not returned for evaluation.To keep components from shifting within the package, the product storage cradles are intentionally snug.The heads of the braided loop components snap into their packaging cavities to avoid inadvertent loop disturbance during removal from their cradles.Removal of a loop from the tray using the distal end (head) can result in weakening, bending or complete fracture between the head and shaft.The correct method of retrieval is to push the head of the component from the back of the cradle which will pop it free.Complaint history review for three years prior indicated similar allegations for the product code reported.Batch review was unattainable without a valid lot number reported.Engineering evaluation confirmed the product met specifications at the time of distribution.

• 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: 10029215
• MDR Text Key: 190015334
• Report Number: 1219602-2020-00738
• 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: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 06/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2020
• 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: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1