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

Catalog Number 7209485

Device Problems Break (1069); Difficult to Insert (1316); Detachment of Device or Device Component (2907)

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

Event Date 03/20/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that during meniscoplasty, there was a dissociation of the lasso of its basis inserting it inside the barrel, it was not correctly crimped (there was a black line between the metal base and the stem and at the time of the use the device broke off at the level of black line.).The procedure was completed with a backup device with no patient injuries or significant delay.Everything has been removed from the patient.

Manufacturer Narrative

Two suture loop components from a meniscus mender ii set were returned for evaluation.Visual assessment of the devices confirmed the reported complaint of breakage.The tubing has broken were it interfaces with the handle at the weldment.A trend of this nature has been observed with this product in the field, prompting a root cause investigation.This investigation is ongoing.

• 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 west william cannon drive; austin, TX 78735 ; 5123585706
• MDR Report Key: 8545293
• MDR Text Key: 143045687
• Report Number: 1219602-2019-00465
• Device Sequence Number: 1
• Product Code: HWQ
• UDI-Device Identifier: 03596010468482
• UDI-Public: 03596010468482
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Type of Report: Initial,Followup
• Report Date: 05/09/2019

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 Expiration Date: 01/09/2024
• Device Catalogue Number: 7209485
• Device Lot Number: 50780575
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2019
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/17/2019
• Initial Date FDA Received: 04/24/2019
• Supplement Dates Manufacturer Received: 05/08/2019
• Supplement Dates FDA Received: 05/09/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/09/2019
• 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