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

Catalog Number	8532
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The distributor reported on behalf of the customer that the 8532, zone specific ii meniscal repair cannula right anterior was being used on (b)(6) 2024 during a meniscus repair procedure when it was reported ¿during a meniscus repair operation, 8532 was used to create a portal, but the joint part was damage.Since the portal had already been created, no alternative product was used.¿ further assessment questioning found that ¿the junction of the device broke while the suture was passing through.The device was grabbed using a retriever and pulled back to remove it.No other fragments fell into the surgical site." the procedure was completed with a 20-minute delay and no alternate device was used.There was no report of injury, medical intervention, or extended hospitalization for the patient or user.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
The reported device is being returned to conmed for evaluation.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.We will continue to monitor per regulatory requirements to help ensure patient safety.
Additional Manufacturer Narrative
Reported event of the device breaking is confirmed.Examination of the returned used device, item 8532 found cannula tube detached from the handle.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 two-year lot history review shows a total of 1 device for this lot number and failure mode.A two-year review of complaint history revealed there has been a total of 2 complaints, regarding 2 devices, for this device family and failure mode.During this same time frame (b)(4) devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be (b)(4).Per the instructions for use, the user is advised that 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 per regulatory requirements to help ensure patient safety.
Event or Problem Description
The distributor reported on behalf of the customer that the 8532, zone specific ii meniscal repair cannula right anterior was being used on (b)(6) 2024 during a meniscus repair procedure when it was reported ¿during a meniscus repair operation, 8532 was used to create a portal, but the joint part was damage.Since the portal had already been created, no alternative product was used.¿.Further assessment questioning found that ¿the junction of the device broke while the suture was passing through.The device was grabbed using a retriever and pulled back to remove it.No other fragments fell into the surgical site.".The procedure was completed with a 20-minute delay and no alternate device was used.There was no report of injury, medical intervention, or extended hospitalization for the patient or user.This report is being raised due to the reported 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: samantha dewberry ; 525 french road; utica, NY 13502 ; 3152230184
• MDR Report Key: 21239974
• Report Number: 1017294-2025-00009
• Device Sequence Number: 12912837
• Product Code: NBH
• UDI-Device Identifier: 10845854025253
• UDI-Public: (01)10845854025253(11)240521(10)1389919
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2025

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: 8532
• Device Lot Number: 1389919
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2025
• Supplement Date Received by Manufacturer: 02/20/2025
• Initial Report FDA Received Date: 01/27/2025
• Supplement Report FDA Received Date: 03/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/21/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic