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

Catalog Number 7209485

Device Problem Separation Failure (2547)

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

Event Date 08/16/2019

Event Type  malfunction  

Event Description

It was reported that during a meniscus repair procedure, the two loop retrievers were already disassembled between head and shaft when package was opened.No backup device was available, it is unknown how the procedure was completed.No delay or patient injuries were reported.

Manufacturer Narrative

One 7209485 disposable meniscus mender ii set used for treatment, was partially returned for evaluation.Two loop snare components were returned.The complaint stated: ¿the two loop retrievers were already disassembled between head and shaft when package was opened.¿ the allegation was confirmed.Policy is to return product as found.The return did not consisted of all set components.The two snares were returned damaged.The heads were broken off the shafts.The snare loops were disturbed.To avoid components from shifting within the package, individual component storage cradles are intentionally snug.The heads of the braided loop components snap into their packaging cavities.Use of the distal end (head) to remove snare loops from the tray may result in weakening, bending or complete fracture between at the head and shaft connection.Proper method of retrieval is to push the head of the component from the back of the cradle to pop it free.Engineering evaluation confirmed the product met current 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 boulevard; mansfield MA 02048
• MDR Report Key: 8957806
• MDR Text Key: 156351554
• Report Number: 1219602-2019-01088
• 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: 09/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/08/2023
• Device Catalogue Number: 7209485
• Device Lot Number: 50769342
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2019
• Date Manufacturer Received: 09/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1