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

Catalog Number 7209485

Device Problem Material Separation (1562)

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

Event Date 05/12/2020

Event Type  malfunction  

Event Description

It was reported that during an arthroscopy, when removing the wire loop from the plastic packaging of the set meniscus mender, it broke loose from the handle ¿nob¿.The procedure was completed without significant delay using the same 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

The reported disposable meniscus mender ii kit, intended for use in treatment, has not been returned for evaluation.Without the reported product a visual or functional evaluation cannot be performed and the customers complaint cannot be confirmed.However, a trend of this nature has been observed with this product in the field, prompting a root cause investigation.As a process improvement, smith and nephew worked with our supplier, to implement a process change to improve the suture capture loop¿s device strength.In addition the laser welding process was adjusted and a revalidation was conducted.The process change was implemented into production.These changes were conducted in parallel to the root cause investigation.Once the root cause investigation is finalized, a subsequent process change may or may not be required to meet the new design requirements.Complaint history and batch review was unattainable without a valid lot number and product code provided although query using entire meniscus mender family indicated similar allegations.Further investigation is not warranted at this time.

• 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: 10136106
• MDR Text Key: 194614943
• Report Number: 1219602-2020-00867
• Device Sequence Number: 1
• Product Code: HWQ
• UDI-Device Identifier: 03596010468482
• UDI-Public: 3596010468482
• 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: 08/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7209485
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/14/2020
• Initial Date FDA Received: 06/09/2020
• Supplement Dates Manufacturer Received: 08/06/2020
• Supplement Dates FDA Received: 08/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1