MAUDE Adverse Event Report: CONMED LARGO BIOSCREW HYPERFLEX GUIDEWIRE NITINOL 18.5 IN STER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	C8027D
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The sales representative reported on behalf of the customer, that the c8027d bioscrew hyperflex guidewire nitinol 18.5 in ster was being used during an acl reconstruction procedure on (b)(6) 2024 date when it was reported ¿the acl guide wire was in the tibia, screw was inserted, the guide wire was stuck, upon pulling the tip broke and had to be retrieved.Fluoroscopy had to be brought in to certify the fragment was removed.¿.It was also reported ¿they backed out the screw and grabbed the fragment with a snap.¿.The procedure was completed with a 10-minute delay.The current status of the patient was reported as ¿unharmed, will be discharged as normal.¿ there was no report of injury, medical intervention, or extended hospitalization to the patient or user.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
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; however photographic evidence was provided.The root cause cannot be determined, however, based upon the photos and the ifu, the likely cause of this event was the kinking and then use of a kinked guidewire.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 2 complaints, regarding 2 devices, for this device family and failure mode.During this same time frame (b)(4) have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, (b)(4).Per the instructions for use, the user is advised to 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.
Event or Problem Description
The sales representative reported on behalf of the customer, that the c8027d bioscrew hyperflex guidewire nitinol 18.5 in ster was being used during an acl reconstruction procedure on (b)(6) 2024 date when it was reported ¿the acl guide wire was in the tibia, screw was inserted, the guide wire was stuck, upon pulling the tip broke and had to be retrieved.Fluoroscopy had to be brought in to certify the fragment was removed.¿.It was also reported ¿they backed out the screw and grabbed the fragment with a snap.¿ the procedure was completed with a 10-minute delay.The current status of the patient was reported as ¿unharmed, will be discharged as normal.¿.There was no report of injury, medical intervention, or extended hospitalization to the patient or user.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: BIOSCREW HYPERFLEX GUIDEWIRE NITINOL 18.5 IN STER
• Common Device Name: 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: 18967568
• Report Number: 1017294-2024-00035
• Device Sequence Number: 6035685
• Product Code: LXH
• UDI-Device Identifier: 10845854041727
• UDI-Public: (01)10845854041727(17)281226(10)1361054
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 05/06/2024

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 Catalogue Number: C8027D
• Device Lot Number: 1361054
• 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: 03/05/2024
• Supplement Date Received by Manufacturer: 04/09/2024
• Initial Report FDA Received Date: 03/25/2024
• Supplement Report FDA Received Date: 05/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/28/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic