MAUDE Adverse Event Report: CONMED LARGO Y-KNOT FLEX 1.3MM ALL-SUTURE ANCHOR; 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	08/31/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The sales representative reported on behalf of the customer, that the y1301, y-knot flex 1.3mm all-suture anchor was being used during a shoulder instability procedure on (b)(6) 2023 date when it was reported ¿unclear if the tip of the driver fell into the surgical site or if it fell outside the surgical site.The surgeon couldn´t find the tip in the surgical site.But the surgeon has decided that the patient will undergo an x-ray examination at the next return visit.The surgery was carried out without delay.To the best of (b)(6) knowledge, the patient has not suffered any damage because of what happened.No replacement anchor was used.The surgeon left the anchor whose driver (tip) had broken.The surgeon then set two more anchors of the same type which worked as they should.¿.The procedure was completed with the same alternate device and there was no report of injury, medical intervention, or extended hospitalization to the patient or user.This report is being raised on the reported malfunction with potential for injury upon reoccurrence.
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
The sales representative reported on behalf of the customer, that the y1301, y-knot flex 1.3mm all-suture anchor was being used during a shoulder instability procedure on (b)(6) 2023 date when it was reported ¿unclear if the tip of the driver fell into the surgical site or if it fell outside the surgical site.The surgeon couldn´t find the tip in the surgical site.But the surgeon has decided that the patient will undergo an x-ray examination at the next return visit.The surgery was carried out without delay.To the best of katarina's knowledge, the patient has not suffered any damage because of what happened.No replacement anchor was used.The surgeon left the anchor whose driver (tip) had broken.The surgeon then set two more anchors of the same type which worked as they should.¿.The procedure was completed with the same alternate device and there was no report of injury, medical intervention, or extended hospitalization to the patient or user.This report is being raised on 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 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 8 complaints, regarding 9 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 to 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 unintended contact with other surgical instruments during use to prevent damage or breakage.Inspect instruments after use to ensure they have not been damaged.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.

• Brand Name: Y-KNOT FLEX 1.3MM ALL-SUTURE ANCHOR
• 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: samantha dewberry ; 525 french road; utica, NY 13502 ; 3152230184
• MDR Report Key: 17789150
• Report Number: 1017294-2023-00086
• Device Sequence Number: 6252936
• Product Code: MBI
• UDI-Device Identifier: 10845854021651
• UDI-Public: (01)10845854021651(17)280625(10)1325435
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K111779
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2023

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: 1325435
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2023
• Supplement Date Received by Manufacturer: 10/27/2023
• Initial Report FDA Received Date: 09/21/2023
• Supplement Report FDA Received Date: 11/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2023
• 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: Unknown
• Patient Ethnicity: Non Hispanic