MAUDE Adverse Event Report: CONMED LARGO ZONE SPECIFIC; ACCESSORIES,ARTHROSCOPIC

Catalog Number	8530
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2024
Type of Reportable Event	Malfunction
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.
Event or Problem Description
A distributor reported on behalf of a customer that the 8530, zone specific ii meniscal repair cannula, right posterior device was being used during an acl reconstruction procedure on (b)(6) 2024, and "zone specific ii cannula broken easily during surgery.Surgeon followed the ifu and held softly on the meniscus.Surgeon is experienced in using zone specific." follow-up assessment found that all fragments or components were retrieved from the surgical site using an arthroscopic grasper.The procedure was completed without the use of an alternate device.There was no report of injury, medical/surgical intervention, or extended hospitalization for the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
The device will not be returned for evaluation, however the provided photographic evidence exhibits the reported event.A likely cause of this event is due to the application of excessive force and/ or collision with another instrument during use.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 2 year lot history review shows a total of 1 device for this lot number and failure mode.(b)(4).Per the instructions for use, the user is advised the following: the zone specific ii meniscal repair system is a limited reuse item.The reuse schedule will be determined from the care taken during use.Using the device in a pry bar type manner will greatly reduce the life of the component.We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
A distributor reported on behalf of a customer that the 8530, zone specific ii meniscal repair cannula, right posterior device was being used during an acl reconstruction procedure on 21jul24, and ¿zone specific ii cannula broken easily during surgery.Surgeon followed the ifu and held softly on the meniscus.Surgeon is experienced in using zone specific.¿ follow-up assessment found that all fragments or components were retrieved from the surgical site using an arthroscopic grasper.The procedure was completed without the use of an alternate device.There was no report of injury, medical/surgical intervention, or extended hospitalization for the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: ZONE SPECIFIC
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer (Section G): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer Contact: beth madeline ; 11311 concept blvd; largo, FL 33773 ; 7274708358
• MDR Report Key: 19927541
• Report Number: 1017294-2024-00093
• Device Sequence Number: 15474556
• Product Code: NBH
• UDI-Device Identifier: 10845854025239
• UDI-Public: (01)10845854025239(11)240405(10)1380918
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 8530
• Device Lot Number: 1380918
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2024
• Supplement Date Received by Manufacturer: 08/14/2024
• Initial Report FDA Received Date: 08/07/2024
• Supplement Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic