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

Catalog Number	Y18TN-FA
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/03/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The sales representative reported on behalf of the customer, that y18tn-fa, trushot fa w/all-suture anchor w/hi-fi sutures w/needles was being used on (b)(6) 2024 during a biceps tenodesis procedure when it was reported ¿metal tyne break off.¿.Further assessment questioning found that ¿the fragment was buried and left in the humeral bone.It was confirmed by x-ray to be buried in bone.Removing would have caused more damage.¿.The procedure was completed with a 15-minute delay and there was no report if medical intervention, or extended hospitalization for the patient or user.This report is being raised on reported injury due to the patient retaining a foreign body.
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.
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 capa review board meeting, a possible cause of this event is rotation of the device about its axis, or 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.A two-year lot history review shows a total of 1 device for this lot number and failure mode.Per the instructions for use, the user is advised when removing trushot fa 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.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 y18tn-fa, trushot fa w/all-suture anchor w/hi-fi sutures w/needles was being used on (b)(6) 2024 during a biceps tenodesis procedure when it was reported ¿metal tyne break off.¿.Further assessment questioning found that ¿the fragment was buried and left in the humeral bone.It was confirmed by x-ray to be buried in bone.Removing would have caused more damage.¿.The procedure was completed with a 15-minute delay and there was no report if medical intervention, or extended hospitalization for the patient or user.This report is being raised on reported injury due to the patient retaining a foreign body.

• 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: 20517239
• Report Number: 1017294-2024-00120
• Device Sequence Number: 7880915
• Product Code: MBI
• UDI-Device Identifier: 20653405988394
• UDI-Public: (01)20653405988394(17)290211(10)1368354
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K182446
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2024

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-FA
• Device Lot Number: 1368354
• 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: 10/03/2024
• Supplement Date Received by Manufacturer: 11/12/2024
• Initial Report FDA Received Date: 10/23/2024
• Supplement Report FDA Received Date: 11/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/13/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: XRAY
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic