MAUDE Adverse Event Report: CONMED LARGO SEQUENT MENISCAL REPAIR DEVICE, CURVED NEEDLE, 4 IMPLANTS; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	MR004C
Medical Device Problem Code	Misfire (2532)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	10/29/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The distributor reported on behalf of their customer that the mr004c, sequent meniscal repair device, curved needle was being used during a meniscus repair procedure on (b)(6) 2023 when it was reported ¿the trigger was not functional in some of the devices and in the others four implants were deployed instead of one implant¿.Further assessment questioning found that another surgery was scheduled for the patient after two months.The medial meniscus of the knee is damaged due to repeated poking.¿.The procedure was completed with an unknown alternate device and a 1-hour delay was also reported.This report is being raised on the reported injury due to damage to the patient¿s medial meniscus requiring an additional procedure.
Additional Manufacturer Narrative
The device is not expected to be returned for evaluation and review.However, the complaint investigation is not complete at this time.A supplemental and final report will be filed following the completion of the complaint investigation.We will continue to monitor for trends through the complaint system to assure patient safety.
Additional Manufacturer Narrative
The device has not been returned to date and no photographic evidence has been provided; therefore, the reported event cannot be verified.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution was found to have met all specifications prior to shipment.A two-year lot history review shows a total of 7 devices for this lot number and failure mode.(b)(4).Per the instructions for use, the user is advised to be familiar with the appropriate surgical technique prior to use of this device.The risk of premature failure is reduced by following the specified instructions for use.Preoperative and operating procedures, including knowledge of surgical techniques and proper placement of the implants are important considerations in the successful utilization of this device.The risk of premature failure is reduced by following the specified instructions for use.Preoperative and operating procedures, including knowledge of surgical techniques and proper placement of the implants are important considerations in the successful utilization of this device.We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
The distributor reported on behalf of their customer that the mr004c, sequent meniscal repair device, curved needle was being used during a meniscus repair procedure on (b)(6) 2023 when it was reported ¿the trigger was not functional in some of the devices and in the others four implants were deployed instead of one implant.¿.Further assessment questioning found that another surgery was scheduled for the patient after two months.The medial meniscus of the knee is damaged due to repeated poking.¿.The procedure was completed with an unknown alternate device and a 1-hour delay was also reported.This report is being raised on the reported injury due to damage to the patient¿s medial meniscus requiring an additional procedure.

• Brand Name: SEQUENT MENISCAL REPAIR DEVICE, CURVED NEEDLE, 4 IMPLANTS
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer (Section G): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer Contact: samantha dewberry ; 525 french road; utica, NY 13502 ; 3152230184
• MDR Report Key: 18181231
• Report Number: 1017294-2023-00105
• Device Sequence Number: 15390093
• Product Code: MBI
• UDI-Device Identifier: 10845854036587
• UDI-Public: (01)10845854036587(17)280416(10)1307320
• Combination Product (Y/N): N
• Initial Reporter Country: JO
• PMA/510(K) Number: K102339
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: MR004C
• Device Lot Number: 1307320
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2023
• Supplement Date Received by Manufacturer: 12/19/2023
• Initial Report FDA Received Date: 11/21/2023
• Supplement Report FDA Received Date: 01/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 42 YR
• Patient Sex: Female
• Patient Weight: 55 KG
• Patient Ethnicity: Non Hispanic