MAUDE Adverse Event Report: CONMED LARGO ARGO; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	SPK475
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	11/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Update: evaluation: the reported problem of the titanium part is dismantled by cutting the suture of the device was confirmed.Examination of the returned used device, item spk475, found the titanium tip detached from the hex driver assembly.Machined screw found still attached to the driver assembly.However, threader assembly was not returned for the evaluation.Examination was performed per print spk475.Root cause cannot be determined, however, based upon photos of the device; a possible cause of this event could be excessive force.The device will not be returned for evaluation, but photographic evidence has been provided.Root cause cannot be determined, however, based upon photos of the device; 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.(b)(4).Per the instructions for use, the user is advised to inspect all instruments for damage prior to and after the use.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 device, spk475, 4.75 mm argo knotless sp anchor, was being used during a rotator repair procedure on (b)(6) 2024 when it was reported, ¿the titanium part is dismantled by cutting the suture of the device.¿.Further assessment found that there was a detachment of components that was retrieved using pliers after x-ray.This caused a 3-hour delay in the procedure; however, the procedure was completed using another spk475 device.There was no report of injury, medical intervention, or hospitalization for the patient.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 for trends through the complaint system to assure patient safety.
Event or Problem Description
The distributor reported on behalf of their customer that the device, spk475, 4.75 mm argo knotless sp anchor, was being used during a rotator repair procedure on (b)(6) 2024 when it was reported, ¿the titanium part is dismantled by cutting the suture of the device.¿.Further assessment found that there was a detachment of components that was retrieved using pliers after x-ray.This caused a 3-hour delay in the procedure; however, the procedure was completed using another spk475 device.There was no report of injury, medical intervention, or hospitalization for the patient.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Event or Problem Description
The distributor reported on behalf of their customer that the device, spk475, 4.75 mm argo knotless sp anchor, was being used during a rotator repair procedure on (b)(6) 2024 when it was reported, ¿the titanium part is dismantled by cutting the suture of the device.¿.Further assessment found that there was a detachment of components that was retrieved using pliers after x-ray.This caused a 3-hour delay in the procedure; however, the procedure was completed using another spk475 device.There was no report of injury, medical intervention, or hospitalization for the patient.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
The device will not be returned for evaluation, but photographic evidence has been provided.Root cause cannot be determined, however, based upon photos of the device; 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 8 complaints, regarding 8 devices, for this device family and failure mode.During this same time frame 40,246 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 0.0002.Per the instructions for use, the user is advised to inspect all instruments for damage prior to and after the use.We will continue to monitor for trends through the complaint system to assure patient safety.

• Brand Name: ARGO
• 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: john berga ; 11311 concept blvd; largo, FL 33773 ; 7273995358
• MDR Report Key: 20817553
• Report Number: 1017294-2024-00141
• Device Sequence Number: 8928611
• Product Code: MBI
• UDI-Device Identifier: 20845854649814
• UDI-Public: (01)20845854649814(17)250428(30)1(10)1350582
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K220757
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/05/2025

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 Expiration Date: 04/28/2025
• Device Catalogue Number: SPK475
• Device Lot Number: 1350582
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2024
• Supplement Date Received by Manufacturer: 01/15/2025; 01/20/2025
• Initial Report FDA Received Date: 12/02/2024
• Supplement Report FDA Received Date: 01/15/2025; 02/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2023
• 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
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic