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

Catalog Number C8026

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/23/2023

Event Type  Injury  

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 for trends through the complaint system to assure patient safety.H3 : device not yet received.

Event Description

The customer reported on behalf of their customer that the c8026, bioscrew hyperflex guidewires, 356mm (1 4 in.), qty 5, was being used during a ligamentoplasty procedure on (b)(6) 2023 when it was reported ¿nitinol guide pin left in the patient's knee following ligamentoplasty: discovered post-op during follow-up imaging.¿.Further assessment questioning found ¿discovered post op, no need for retrieve.¿.The procedure was completed and there was no report of medical intervention, or hospitalization for the patient or user.This report is being raised on the reported injury due to patient retaining a foreign body.

Event Description

The customer reported on behalf of their customer that the c8026, bioscrew hyperflex guidewires, 356mm (1 4 in.), qty 5, was being used during a ligamentoplasty procedure on (b)(6) 23 when it was reported ¿nitinol guide pin left in the patient's knee following ligamentoplasty: discovered post-op during follow-up imaging.¿.Further assessment questioning found ¿discovered post op, no need for retrieve.¿.The procedure was completed and there was no report of medical intervention, or hospitalization for the patient or user.This report is being raised on the reported injury due to patient retaining a foreign body.

Manufacturer Narrative

Visual examination of returned used device found the nitinol wire bent and broken off at the etch line.Broken piece is approximately 1.760 -inches and was not returned for evaluation.Note: total length of the wire should be 14.00 +/-.05, device was broken off at 12.240 inches.This is a technique dependent device, and the most likely cause of this issue is user related.A device history review could not be conducted as a lot number was not provided.A 2 year lot history review could not be conducted as a lot number was not provided.A two-year review of complaint history revealed there has been a total of 1 complaint, regarding 1 device, for this device family and failure mode.During this same time frame 14,607 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 0.00007.Per the instructions for use, the user is advised 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: 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: samantha dewberry ; 525 french road; utica, NY 13502 ; 3152230184
• MDR Report Key: 17311469
• MDR Text Key: 318923340
• Report Number: 1017294-2023-00065
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 08/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2023
• 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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 18 YR
• Patient Sex: Male
• Patient Weight: 50 KG
• Patient Ethnicity: Non Hispanic