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

Model Number 7209485

Device Problem Break (1069)

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

Event Date 07/16/2020

Event Type  malfunction  

Event Description

It was reported that during the surgery, the shaft broke and got separated from the gripper when it came out of the package.The surgery was delay by 10 minutes.It is unknown how the surgery was completed.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

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 indicated similar allegations for the lot number reported.Batch review indicated no condition, product or procedure failure that supported the allegation.Further investigation resulted with initiation of a corrective action and potential process change.Engineering evaluation confirmed the product met specifications at the time of distribution.The product family allegation rate of occurrences continue to be monitored via surveillance.

• 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: 10390156
• MDR Text Key: 202364644
• Report Number: 1219602-2020-01225
• 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: 09/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2020
• 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: 2046125
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1