MAUDE Adverse Event Report: CONMED LARGO BIOSCREW HYPERFLEX GUIDEWIRES, 356MM (14 IN.), QTY 5; LXH - ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number C8026

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/19/2023

Event Type  Injury  

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 Description

A sales representative reported on behalf of a customer that the device, c8026, bioscrew hyperflex guidewires, 356mm (14 in.), was being used during an unnamed surgical procedure on (b)(6) 2023 when the ¿acl screw guide wire tip broke off in patient during procedure¿.Further assessment found that the fragment is "believed to be lodged" in the patient.The procedure was delayed for 5 minutes.There was no report of medical intervention or prolonged hospitalization to the patient.This report is being raised due to the reported injury of fragmentation with a retained foreign body.

Event Description

Update: per assessment received on 19oct23 "the piece remained in the patient- it was interferes in a "safe" spot according to dr.Guide wire inserted, acl screw implanted, upon removal he had to yank on the wire to remove, tip was broken.".A sales representative reported on behalf of a customer that the device, c8026, bioscrew hyperflex guidewires, 356mm (14 in.), was being used during an unnamed surgical procedure on (b)(6) 2023 when the ¿acl screw guide wire tip broke off in patient during procedure¿.Further assessment found that the fragment is "believed to be lodged" in the patient.The procedure was delayed for 5 minutes.There was no report of medical intervention or prolonged hospitalization to the patient.This report is being raised due to the reported injury of fragmentation with a retained foreign body.

Manufacturer Narrative

The device will not be returned for evaluation however a photograph was provided.Review of the photograph; however, could not confirm the reported event.A 2 year lot history review could not be conducted as a lot number was not provided.A device history record review could not be conducted as a lot number was not provided.(b)(4).Per the instructions for use, the user is advised the following: to avoid damage or breakage during use, do not use excessive force on guidewire.Inspect guidewire prior to use and after removal to ensure it is in good physical condition and functions properly.Do not use if product is damaged.Do not kink (sharply bend) the guidewire prior to or during insertion.Breakage or insertion difficulty may occur if the interference screw is used with a kinked guidewire.We will continue to monitor for trends through the complaint system to assure patient safety.

• Brand Name: BIOSCREW HYPERFLEX GUIDEWIRES, 356MM (14 IN.), QTY 5
• Type of Device: LXH - ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 17852349
• MDR Text Key: 324703269
• Report Number: 1017294-2023-00091
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: C8026
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Ethnicity: Non Hispanic