MAUDE Adverse Event Report: CONMED LARGO SPECTRUM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	C6380
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported device has been returned to conmed; however, the complaint investigation has not been completed.A supplemental and final report will be filed following the completion of the complaint investigation.We will continue to monitor per regulatory requirements to help ensure patient safety.
Event or Problem Description
A sales representative reported on behalf of a customer that the c6380, spectrum ii suture hook, disposable, 45° right device was used in a labral repair procedure on (b)(6) 2024, and ¿labral repair using spectrum2 with dispo hooks.The hook broke off when attempting to pass suture around bicep tendon.No known patient impact at this time¿.Per further assessment, all fragments were retrieved with "likely a grasper".The procedure was completed as normal with a "replacement spectrum hook", and a delay of unknown duration.There was no injury, medical/surgical intervention or extended hospitalization required for the patient, whose status is described as "fine".This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Event or Problem Description
A sales representative reported on behalf of a customer that the c6380, spectrum ii suture hook, disposable, 45° right device was used in a labral repair procedure on (b)(6) 2024, and ¿labral repair using spectrum2 with dispo hooks.The hook broke off when attempting to pass suture around bicep tendon.No known patient impact at this time¿.Per further assessment, all fragments were retrieved with "likely a grasper".The procedure was completed as normal with a "replacement spectrum hook", and a delay of unknown duration.There was no injury, medical/surgical intervention or extended hospitalization required for the patient, whose status is described as "fine".This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
The evaluation of returned used device c6360 performed per print c6360 found the hook broken off and detached from shaft.Also, the shaft was slightly bent.The broken hook was not returned for the evaluation.Root cause cannot be determined, however, based upon evaluation of the device and the ifu, a possible cause of this event could be excessive force.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.This is the only complaint for this lot number and failure mode within the past two years.A two-year review of complaint history revealed there has been a total of 19 reports, regarding 19 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 the following: avoid lateral stresses to the instruments or device function may be compromised.There is an increased risk of hook or needle breakage and unintentional patient injury may result.We will continue to monitor per regulatory requirements to help ensure patient safety.

• Brand Name: SPECTRUM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 20880671
• Report Number: 1017294-2024-00145
• Device Sequence Number: 8839172
• Product Code: LXH
• UDI-Device Identifier: 10845854018545
• UDI-Public: (01)10845854018545(17)291016(10)1417476
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2025

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: C6380
• Device Lot Number: 1417476
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2024
• Supplement Date Received by Manufacturer: 01/09/2025
• Initial Report FDA Received Date: 12/09/2024
• Supplement Report FDA Received Date: 01/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic