MAUDE Adverse Event Report: CONMED LARGO Y-KNOT RC ALL-SUTURE ANCHOR, WITH TWO NO. 2; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	YRC02
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/02/2023
Type of Reportable Event	Serious Injury
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.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
The sales representative reported on behalf of the customer that the device yrc02 y-knot rc all-suture anchor, with two no.2 was being used on (b)(6) 2023 during a rotator cuff tear surgery and ¿during rotator cuff reconstruction, one of the two metal tips of the yrc02 setting tool broke off¿.Further assessment discovered that the fragment was not retrieved, ¿no, because it stayed in situ.The damage for the patient would be to big, if they have to remove it.¿ at this time a 2nd surgery to remove the fragment has not been planned.There was no medical/surgical intervention or prolonged hospitalization required for the patient/user.The procedure was completed without an alternate device and there was no delay.The patient is reported as "no issues so far".This report is being raised on the basis of injury due to fragment remaining in the patient.
Additional Manufacturer Narrative
The device has not been returned to date, but photographic evidence has been 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 1 report, regarding 1 device, 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 0.00001.Per the instructions for use, the user is advised the following: 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.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 device yrc02 y-knot rc all-suture anchor, with two no.2 was being used on (b)(6) 2023 during a rotator cuff tear surgery and ¿during rotator cuff reconstruction, one of the two metal tips of the yrc02 setting tool broke off¿.Further assessment discovered that the fragment was not retrieved, ¿no, because it stayed in situ.The damage for the patient would be to big, if they have to remove it.¿ at this time a 2nd surgery to remove the fragment has not been planned.There was no medical/surgical intervention or prolonged hospitalization required for the patient/user.The procedure was completed without an alternate device and there was no delay.The patient is reported as "no issues so far".This report is being raised on the basis of injury due to fragment remaining in the patient.

• Brand Name: Y-KNOT RC ALL-SUTURE ANCHOR, WITH TWO NO. 2
• 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: 16325126
• Report Number: 1017294-2023-00010
• Device Sequence Number: 18116643
• Product Code: MBI
• UDI-Device Identifier: 10845854080542
• UDI-Public: (01)10845854080542(17)270614(10)1252515
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K133224
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2023

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: YRC02
• Device Lot Number: 1252515
• 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: 02/02/2023
• Supplement Date Received by Manufacturer: 04/05/2023
• Initial Report FDA Received Date: 02/08/2023
• Supplement Report FDA Received Date: 04/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 20 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic