MAUDE Adverse Event Report: CONMED LARGO TRUSHOT; 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	01/30/2025
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.We will continue to monitor per regulatory requirements to help ensure patient safety.
Event or Problem Description
The customer reported that the y18tn, 1.8mm,all-sutr anch w/2-#2 (5metric) hi-fi suture w/needles, was being used on (b)(6) 2025 during a left shoulder arthroscopy procedure when it was reported ¿first device failed, second device failed, not sure which device tip broke into bone, see md operative note, x- ray completed, md not going back into retrieve.¿.Further assessment questioning found that ¿the first anchor deployed did not hold and the second anchor was deployed and also did not hold and the small metal fork on the deploying mechanism malfunctioned and broke off in the medullary canal of the humerus.The piece of metal is very small and within the medullary canal and any attempt to try and retrieve it would most definitely result in more damage than benefit.No excessive force was used.No additional complications to my knowledge.We did obtain fluoroscopic images to ensure that the small piece of metal was indeed in the medullary canal of the humerus where it would not cause problems.".There was no report of medical intervention, or extended hospitalization for the patient or user.This report is being raised on the reported injury due to the patient retaining a foreign body.
Event or Problem Description
The customer reported that the y18tn, 1.8mm,all-sutr anch w/2-#2 (5metric) hi-fi suture w/needles, was being used on (b)(6) 2025 during a left shoulder arthroscopy procedure when it was reported ¿first device failed, second device failed, not sure which device tip broke into bone, see md operative note, x- ray completed, md not going back into retrieve.¿.Further assessment questioning found that ¿the first anchor deployed did not hold and the second anchor was deployed and also did not hold and the small metal fork on the deploying mechanism malfunctioned and broke off in the medullary canal of the humerus.The piece of metal is very small and within the medullary canal and any attempt to try and retrieve it would most definitely result in more damage than benefit.No excessive force was used.No additional complications to my knowledge.We did obtain fluoroscopic images to ensure that the small piece of metal was indeed in the medullary canal of the humerus where it would not cause problems.".There was no report of medical intervention, or extended hospitalization for the patient or user.This report is being raised on the reported injury due to the patient retaining a foreign body.
Additional Manufacturer Narrative
The evaluation and testing of the returned used y18tn, found trushot anchor assembly bent and broken one of the tip forks.The broken anchor tip was not returned for the evaluation.A root cause cannot be determined; however, based upon the ifu and risk document, a possible cause of this event could be that the device was rotated on it axis during the case.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 a total of 1 device for this lot number and failure mode.(b)(4).Per the instructions for use, the user is advised that 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.Avoid lateral loading while inserting the all-suture anchor.We will continue to monitor per regulatory requirements to help ensure patient safety.

• Brand Name: TRUSHOT
• 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: 21503034
• Report Number: 1017294-2025-00031
• Device Sequence Number: 15459004
• Product Code: MBI
• UDI-Device Identifier: 20845854648985
• UDI-Public: (01)20845854648985(17)290203(10)1368346
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: Y18TN
• Device Lot Number: 1368346
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2025
• Supplement Date Received by Manufacturer: 03/26/2025
• Initial Report FDA Received Date: 03/03/2025
• Supplement Report FDA Received Date: 04/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/05/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: X-RAY; X-RAY
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic