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	11/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported that the device, y18tn 1.8mm, all-sutr anch w/2-#2 (5metric) hi-fi sutures w/needles was being used on (b)(6) 2025 and "after placement of hook plate and screws, trushot anchors were used to hold biobrace (as augmentation) on the capsular part during acj stabilization.Upon completion of all steps, final x-ray was taken.Part of the fork tip that holds the all-suture anchor from trushot was found in patient¿s body.To prevent further damage to soft tissue and risk of hook plate displacement, metal tip was left inside patient¿s body.(trushot with y-knot 1.8mm pin was broken intraop).The broken piece was left insitu patient's right shoulder under acromion." the procedure was completed without the use of an alternate device.This report is being raised due to the reported injury of foreign body left in the patient.
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.
Additional Manufacturer Narrative
Reported event "part of the fork tip that holds the all-suture anchor from trushot was found in patient¿s body.To prevent further damage to soft tissue and risk of hook plate displacement, metal tip was left inside patient¿s body¿ was confirmed.The device will not be returned for evaluation, however, photographic evidence has been provided.Root cause cannot be determined, however, based upon provided photos; a possible cause of this event could be 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.(b)(4).Per the instructions for use, the user is advised the following: 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.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.We will continue to monitor per regulatory requirements to help ensure patient safety.
Event or Problem Description
The customer reported that the device, y18tn 1.8mm,all-sutr anch w/2-#2 (5metric) hi-fi sutures w/needles was being used on (b)(6) 2025 and "after placement of hook plate and screws, trushot anchors were used to hold biobrace (as augmentation) on the capsular part during acj stabilization.Upon completion of all steps, final x-ray was taken.Part of the fork tip that holds the all-suture anchor from trushot was found in patient¿s body.To prevent further damage to soft tissue and risk of hook plate displacement, metal tip was left inside patient¿s body.(trushot with y-knot 1.8mm pin was broken intraoperation).The broken piece was left insitu patient's right shoulder under acromion." the procedure was completed without the use of an alternate device.This report is being raised due to the reported injury of foreign body left in the patient.

• 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: robin drum ; 11311 concept blvd; largo, FL 33773 ; 8653881978
• MDR Report Key: 23719843
• Report Number: 1017294-2025-00122
• Device Sequence Number: 8469636
• Product Code: MBI
• UDI-Device Identifier: 20845854648985
• UDI-Public: (01)20845854648985(17)300729(10)1481574
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K182446
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2025

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: Y18TN
• Device Lot Number: 1481574
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2025
• Supplement Date Received by Manufacturer: 12/05/2025
• Initial Report FDA Received Date: 12/04/2025
• Supplement Report FDA Received Date: 12/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic