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

Catalog Number 7209485

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 01/29/2019

Event Type  malfunction  

Event Description

It was reported that during a procedure, a jelcos was passed with an ultrabraid and then a jelco was passed to rescue the suture, the handle of the meniscus mender was introduced inside the jelco, the ultrabraid was rescued through the handle; on the monitor was showed that the handle was completely loose from the base.The handle of the patient's joint was removed in its entirety.No patient injuries were reported.

Manufacturer Narrative

One (b)(4) disposable meniscus mender ii set returned.The complaint stated: ¿the handle was completely loose from the base.¿ all components are present.The braided loops themselves are damaged.The inserter shaft portion of the loop components are bent.One braid has been severed from its distal tip.The spinal needles are bent and bowed.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 cavities to avoid inadvertent loop disturbance during removal from their cradles.Using the distal end (head) to removal a loop from the tray can result in bending or complete fracture between the head and shaft.The most successful method of retrieval is to push the head of the component from the back of the cradle to pop it free.Recent engineering evaluation confirmed this product meets specifications.Occurrence of allegations are monitored via surveillance.Correction in: health professional: yes occupation: other_health_care_professional health professional should be marked, company representative: should not be marked.Additional information in : address line 1: (b)(4).Foreign city: (b)(4).

Event Description

It was reported that during a procedure, a jelcos was passed with an ultrabraid and then a jelco was passed to rescue the suture, the handle of the meniscus mender was introduced inside the jelco, the ultrabraid was rescued through the handle; on the monitor was showed that the handle was completely loose from the base.Delay more that 30 minutes was reported.The handle was completely removed from the patient¿s joint.No patient injuries were reported.

• Brand Name: SET MENISCUS MENDER II DISPOSABLE
• Type of Device: PASSER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer Contact: jim gonzales ; 7000 w william cannon drive; austin, TX 78735 ; 5123585706
• MDR Report Key: 8316991
• MDR Text Key: 135702923
• Report Number: 1219602-2019-00160
• Device Sequence Number: 1
• Product Code: HWQ
• UDI-Device Identifier: 03596010468482
• UDI-Public: 03596010468482
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K885311
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/02/2022
• Device Catalogue Number: 7209485
• Device Lot Number: 50694645
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/25/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1