MAUDE Adverse Event Report: CONMED LARGO TRUSHOT; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	YSTN20
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2025
Type of Reportable Event	Malfunction
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 per regulatory requirements to help ensure patient safety.
Event or Problem Description
The distributor reported on behalf of their customer that the device, ystn20, trushot w/shallow allsuture anchor w/hi-fi suture w/needles, was being used during an open elbow ligament repair procedure on (b)(6) 2025 when it was reported, ¿drill bit was broken when surgeon was drilling half-way.Surgeon followed ifu and is experienced in using trushot.¿.There was no report of injury, medical intervention, or hospitalization for the patient.Further assessment questions were asked and found that there was fragmentation that fell into the surgical site; however, all fragmentation was retrieved.The procedure was completed with an alternate device.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
The device will not be returned for evaluation, but photographic evidence has been provided.A root cause cannot be determined; however, based upon photographic evidence of the device, a possible cause of this event could be the use of excessive force.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 8 complaints, regarding (b)(4) devices, 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 (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.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.Avoid unintended contact with other surgical instruments during use to prevent damage or breakage.We will continue to monitor per regulatory requirements to help ensure patient safety.
Event or Problem Description
The distributor reported on behalf of their customer that the device, ystn20, trushot w/shallow all suture anchor w/hi-fi suture w/needles, was being used during an open elbow ligament repair procedure on (b)(6) 2025 when it was reported, ¿drill bit was broken when surgeon was drilling half-way.Surgeon followed ifu and is experienced in using trushot.¿.There was no report of injury, medical intervention, or hospitalization for the patient.Further assessment questions were asked and found that there was fragmentation that fell into the surgical site; however, all fragmentation was retrieved.The procedure was completed with an alternate device.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.

• 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: john berga ; 11311 concept blvd; largo, FL 33773 ; 7273995358
• MDR Report Key: 22139816
• Report Number: 1017294-2025-00057
• Device Sequence Number: 20886896
• Product Code: MBI
• UDI-Device Identifier: 20845854649005
• UDI-Public: (01)20845854649005(17)260808(10)1333521
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K182439
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/08/2026
• Device Catalogue Number: YSTN20
• Device Lot Number: 1333521
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2025
• Supplement Date Received by Manufacturer: 06/11/2025
• Initial Report FDA Received Date: 06/04/2025
• Supplement Report FDA Received Date: 06/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2023
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic