MAUDE Adverse Event Report: CONMED CORPORATION SEQUENT MENISCAL REPAIR DEVICE, CURVED NEEDLE, 7 IMPLANTS; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number MR007C

Device Problems Break (1069); Failure to Eject (4010)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

The reported device is expected to be returned to conmed for evaluation.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

On behalf of the customer, the distributor reported an issue with the sequent meniscal repair device, curved needle, 7 implants, item # mr007c, lot # 940330 occurring on an unknown date during an unknown surgical procedure.It was reported that when the device was used, one implant was broken.Said to shoot did not come out other implants.Information obtained on (b)(6) 2019 clarified that the issue occurred at the beginning of the procedure after placing 1 suture and while trying to place the second suture.The procedure was successfully completed after removing the meniscus with no reported delay.There was no additional medical surgical intervention required.Additional information obtained confirmed that no debris fell into the patient, nothing broke apart.To date, although multiple attempts have been made to gather additional clarification, no other information has been provided.This report is raised on the basis of a reported patient injury (the removal of the meniscus).

Manufacturer Narrative

At time of filing, despite numerous requests over the past month to obtain the device for return to conmed for evaluation, the device has not been located or returned.The customer's complaint of "one implant was broken.Said to shoot did not come out other implants" is inconclusive.The manufacturing documents from the device history record have been reviewed and found no abnormalities that would contribute to this issue.A lot history review was conducted and found no other complaints for this lot number and failure mode.A two-year review of complaint history revealed there has been a total of 3 complaints, regarding 3 devices, for this device family and failure mode.(b)(4).The instructions for use (ifu) provides the user with information regarding proper care and use of this device.The ifu also advises the user that preoperative and operating procedures, including knowledge of surgical techniques and proper placement of the implants, are important considerations in the successful utilization of the device.The device should be inspected for damage prior to use.Do not use a damaged device.Improper insertion technique may cause breakage of the device, implant and/or suture or premature failure.A determination for further investigation has been initiated.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: SEQUENT MENISCAL REPAIR DEVICE, CURVED NEEDLE, 7 IMPLANTS
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): CONMED CORPORATION; 11311 concept blvd; largo FL 33773 4908
• MDR Report Key: 8420519
• MDR Text Key: 138790844
• Report Number: 1017294-2019-00027
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• PMA/PMN Number: K102339
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Type of Report: Initial,Followup
• Report Date: 04/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/30/2023
• Device Catalogue Number: MR007C
• Device Lot Number: 940330
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other