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	Foreign Body In Patient (2687)
Date of Event	01/17/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A sales representative reported on behalf of a customer that the y1301, y-knot flex 1.3mm all-suture anchor device was being used on (b)(6) 2024, and ¿during surgery for bankart repair, the surgeon found that 2mm metal fork tip of the 1.3mm yknot flex insertion handle was broken and was retained inside glenoid bone.¿.The procedure was completed with the use of stryker iconix all suture anchors and with "about 20mins delay in surgery for waiting the x-ray confirmation.".There was no medical/surgical intervention, or extended hospitalization for the patient.This report is being raised on the basis of the reported injury of retained foreign body.
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.
Additional Manufacturer Narrative
Additional information: the correct lot number has been provided.Sections d.4 and h.4 have been updated to reflect this information.Additionally, 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 this is the only event for this lot number and failure mode.Examination of the returned used device, item (b)(6) confirm the reported problem and found broken off one of the anchor forks.Broken tip is approximately 0.070 long and was not returned for evaluation.Anchor shaft found slightly bent.Root cause cannot be determined, however, based upon evaluation of the device and ifu; a possible cause of this event could be excessive force.A two-year lot history review cannot be conducted as a valid lot number was not provided.A device history record (dhr) review cannot be conducted as a valid lot number was not provided.(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.We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
A sales representative reported on behalf of a customer that the y1301, y-knot flex 1.3mm all-suture anchor device was being used on (b)(6) 2024, and ¿during surgery for bankart repair, the surgeon found that 2mm metal fork tip of the 1.3mm yknot flex insertion handle was broken and was retained inside glenoid bone.¿.The procedure was completed with the use of stryker iconix all suture anchors and with "about 20mins delay in surgery for waiting the x-ray confirmation.".There was no medical/surgical intervention, or extended hospitalization for the patient.This report is being raised on the basis of the reported injury of retained foreign body.
Event or Problem Description
A sales representative reported on behalf of a customer that the (b)(6), y-knot flex 1.3mm all-suture anchor device was being used on (b)(6) 2024, and ¿during surgery for bankart repair, the surgeon found that 2mm metal fork tip of the 1.3mm yknot flex insertion handle was broken and was retained inside glenoid bone.¿.The procedure was completed with the use of stryker iconix all suture anchors and with "about 20mins delay in surgery for waiting the x-ray confirmation.".There was no medical/surgical intervention, or extended hospitalization for the patient.This report is being raised on the basis of the reported injury of retained foreign body.
Additional Manufacturer Narrative
Correction: the lot number initially provided with the complaint was incorrect and is thus unknown.Section d.4 has been updated to reflect this finding.Examination of the returned used device, item y1301 confirm the reported problem and found broken off one of the anchor forks.Broken tip is approximately 0.070 long and was not returned for evaluation.Anchor shaft found slightly bent.Root cause cannot be determined, however, based upon evaluation of the device and ifu; a possible cause of this event could be excessive force.A two-year lot history review cannot be conducted as a valid lot number was not provided.A device history record (dhr) review cannot be conducted as a valid lot number was not provided.(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.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: beth madeline ; 11311 concept blvd; largo, FL 33773 ; 7274708358
• MDR Report Key: 18894404
• Report Number: 1017294-2024-00028
• Device Sequence Number: 6410790
• Product Code: MBI
• UDI-Device Identifier: 20845854021658
• UDI-Public: (01)20845854021658(17)230925(10)1344066
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K111779
• 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): 04/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: Y1301
• Device Lot Number: 1344066
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/29/2024
• Supplement Date Received by Manufacturer: 04/11/2024; 04/26/2024
• Initial Report FDA Received Date: 03/13/2024
• Supplement Report FDA Received Date: 04/15/2024; 04/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2023
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic