MAUDE Adverse Event Report: CONMED LARGO Y-KNOT; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	Y1301
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2024
Type of Reportable Event	Malfunction
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.H3 other text : device not yet received.
Event or Problem Description
The distributor reported on behalf of the customer that the device, y1301, y-knot flex 1.3mm all-suture anchor, was being used on (b)(6) 2024 and ¿the surgery was a bankart repair.The surgeon useslski two 1.8 yknot flex anchor and for the final anchor he chose an 1.3mm yknot flex anchor.He drilled the hole and inserted and deployed the anchor.Post deployment on knot tying he saw the entire anchor bailed out also the guide is pretty straight and he saw a small metal tip from the guide stuck in the glenoid.He completed the surgery using another 1.3mm yknot flex anchor.".There was no report of impact or injury for the patient.Per further assessment it was found that the small metal tip was retrieved from the patient.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
The device has not been returned for evaluation to date; however, photographs were provided.Review of the photographs; however, could not confirm the reported event.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 12 reports, regarding 14 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: inspect instruments prior to use to ensure they are in good physical condition and function properly.There should be no loose, broken or misaligned parts.Exercise care in the use of these devices to minimize side or bending loads.Do not use excessive force on instruments to avoid damage or breakage during use.Avoid lateral loading while inserting y-knot anchors.Maintain proper alignment during insertion of anchors and disengagement of drivers.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 the customer that the device, y1301, y-knot flex 1.3mm all-suture anchor, was being used on (b)(6) 2024 and ¿the surgery was a bankart repair.The surgeon useslski two 1.8 yknot flex anchor and for the final anchor he chose an 1.3mm yknot flex anchor.He drilled the hole and inserted and deployed the anchor.Post deployment on knot tying he saw the entire anchor bailed out also the guide is pretty straight and he saw a small metal tip from the guide stuck in the glenoid.He completed the surgery using another 1.3mm yknot flex anchor.".There was no report of impact or injury for the patient.Per further assessment it was found that the small metal tip was retrieved from the patient.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Update: examination of the returned used device found one of the anchor forks broken off.Broken tip is approximately 0.070 long and was not returned for evaluation.Anchor shaft found slightly bent.A likely cause for breakage of the driver fork is the use of 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 the following: inspect instruments prior to use to ensure they are in good physical condition and function properly.There should be no loose, broken or misaligned parts.Exercise care in the use of these devices to minimize side or bending loads.Do not use excessive force on instruments to avoid damage or breakage during use.Avoid lateral loading while inserting y-knot anchors.Maintain proper alignment during insertion of anchors and disengagement of drivers.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 the customer that the device, y1301, y-knot flex 1.3mm all-suture anchor, was being used on 1aug24 and ¿the surgery was a bankart repair.The surgeon useslski two 1.8 yknot flex anchor and for the final anchor he chose an 1.3mm yknot flex anchor.He drilled the hole and inserted and deployed the anchor.Post deployment on knot tying he saw the entire anchor bailed out also the guide is pretty straight and he saw a small metal tip from the guide stuck in the glenoid.He completed the surgery using another 1.3mm yknot flex anchor.".There was no report of impact or injury for the patient.Per further assessment it was found that the small metal tip was retrieved from the patient.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.

• Brand Name: Y-KNOT
• 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: robin drum ; 11311 concept blvd; largo, FL 33773 ; 8653881978
• MDR Report Key: 19972249
• Report Number: 1017294-2024-00095
• Device Sequence Number: 8586118
• Product Code: MBI
• UDI-Device Identifier: 20845854021658
• UDI-Public: (01)20845854021658(17)290129(10)1367592
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K111779
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/05/2024

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: Y1301
• Device Lot Number: 1367592
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2024
• Supplement Date Received by Manufacturer: 09/23/2024; 12/04/2024
• Initial Report FDA Received Date: 08/13/2024
• Supplement Report FDA Received Date: 09/27/2024; 12/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic