MAUDE Adverse Event Report: CONMED LARGO TRUSHOT WITH Y-KNOT 1.8MM ALL-SUTURE ANCHOR; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	Y18TN
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/26/2023
Type of Reportable Event	Serious Injury
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 y18tn, trushot with y-knot 1.8mm all-suture anchor was being used on approximately (b)(6) 2023 and the ¿tine broke off true shot.Could not find the time outside capsule of knee.¿.Per further assessment, "we tried to retrieve from fatty tissue under x-ray for 1 hr could not find it.1/2 the fork broke off the tip on impaction.".There was no report of impact/injury, medical intervention or prolonged hospitalization to the patient.This report is being raised due to the reported injury of fragmentation, although not found in the patient, they cannot produce the piece and its location is unknown.
Event or Problem Description
The sales representative reported on behalf of the customer that the y18tn, trushot with y-knot 1.8mm all-suture anchor was being used on approximately (b)(6) 2023 and the "tine broke off true shot.Could not find the time outside capsule of knee." per further assessment, "we tried to retrieve from fatty tissue under x-ray for 1 hr could not find it.1/2 the fork broke off the tip on impaction." there was no report of impact/injury, medical intervention or prolonged hospitalization to the patient.This report is being raised due to the reported injury of fragmentation, although not found in the patient, they cannot produce the piece and its location is unknown.
Additional Manufacturer Narrative
The device will not be returned, and no photographic evidence was provided.Therefore, a device malfunction cannot be verified.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: preoperative and operating procedures, including knowledge of surgical techniques and proper selection and placement of implants are important considerations in the successful utilization of these devices.Surgeon must choose proper implant size based on specific procedure and patient history.When removing trushot from pilot hole, pull device straight out.Do not rotate or oscillate device about its axis or breakage of inserter tip and/or anchor may result.We will continue to monitor for trends through the complaint system to assure patient safety.

• Brand Name: TRUSHOT WITH Y-KNOT 1.8MM 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: robin drum ; 11311 concept blvd; largo, FL 33773 ; 8653881978
• MDR Report Key: 17895722
• Report Number: 1017294-2023-00094
• Device Sequence Number: 15233575
• Product Code: MBI
• UDI-Device Identifier: 20845854648985
• UDI-Public: (01)20845854648985(17)260131(10)1297412
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K182446
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/28/2023

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 Expiration Date: 01/31/2026
• Device Catalogue Number: Y18TN
• Device Lot Number: 1297412
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2023
• Supplement Date Received by Manufacturer: 11/08/2023
• Initial Report FDA Received Date: 10/09/2023
• Supplement Report FDA Received Date: 11/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic