MAUDE Adverse Event Report: CONMED LARGO Y-KNOT FLEX 1.3MM ALL-SUTURE ANCHOR; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number Y1301

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/04/2022

Event Type  Injury  

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.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

The sales representative reported on behalf of the customer that the y1301, y-knot flex 1.3mm all-suture anchor was being used on (b)(6) 2022 during a bankart procedure when it was reported ¿at surgery while the doctor was placing the 3rd yknot flex 1,3 into the drilling hole, the needle broke, and they suspect one small piece of metal is still in the patient¿s bone but not in the joint.They used a new one and it worked well.¿ further assessment questioning found that ¿one metal piece was probably stuck in the patient, since athroscopical procedure, we could not retrieve it.¿ they attempted to retrieve the fragment by using a non-traumatic grasper.It was also reported ¿no x-ray was performed, and we had to use more anchors.¿.The procedure was completed with the use of an alternate y1301 y-knot anchor and a 15-minute delay was reported during the procedure.There was no report of injury, medical intervention or hospitalization required for the patient.The current status of the patient is ¿fine¿.This report is being raised on the basis of injury due to patient retaining fragmentation of the device.

Event Description

The sales representative reported on behalf of the customer that the y1301, y-knot flex 1.3mm all-suture anchor was being used on 04oct22 during a bankart procedure when it was reported ¿at surgery while the doctor was placing the 3rd yknot flex 1,3 into the drilling hole, the needle broke, and they suspect one small piece of metal is still in the patient¿s bone but not in the joint.They used a new one and it worked well.¿ further assessment questioning found that ¿one metal piece was probably stuck in the patient, since athroscopical procedure, we could not retrieve it.¿ they attempted to retrieve the fragment by using a non-traumatic grasper.It was also reported ¿no x-ray was performed, and we had to use more anchors.¿.The procedure was completed with the use of an alternate y1301 y-knot anchor and a 15-minute delay was reported during the procedure.There was no report of injury, medical intervention or hospitalization required for the patient.The current status of the patient is ¿fine¿.This report is being raised on the basis of injury due to patient retaining fragmentation of the device.

Manufacturer Narrative

Reported event is confirmed.The device is not being returned but photographic evidence was provided that confirmed the reported problem.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 7 complaints, regarding 8 devices, for this device family and failure mode.During this same time frame 35,927 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 instruments prior to use to ensure they are in good physical condition and function properly.There should be no loose, broken or misaligned parts.Do not use excessive force on instruments to avoid damage or breakage during use.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: Y-KNOT FLEX 1.3MM ALL-SUTURE ANCHOR
• Type of Device: 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: 15617258
• MDR Text Key: 301855905
• Report Number: 1017294-2022-00099
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K111779
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/30/2022

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
• Device Operator: Health Professional
• Device Model Number: Y1301
• Device Catalogue Number: Y1301
• Device Lot Number: 1211326
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/05/2022
• Initial Date FDA Received: 10/17/2022
• Supplement Dates Manufacturer Received: 11/07/2022
• Supplement Dates FDA Received: 11/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2021
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic