MAUDE Adverse Event Report: CONMED LARGO BIOSCREW HYPERFLEX; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Catalog Number	C8006D
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/05/2024
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
A sales representative reported on behalf of a customer that the c8006d, guidewire, nitinol 14 in, sterile device was used in an acl reconstruction procedure on (b)(6) 2024 and post-operatively, on (b)(6) 2024, the doctor ¿took post op x-rays of the patient and realized that one of our guide wires for our screws is still in the patient, embedded in the autograft.We are not positive if it is the guidewire from the 8820 acl kit (lot 1422285) or the c8006d guidewire (lot 1183654), both were opened in the case.The patient has no pain or issues at the moment the wire was found during a routine post op x-ray.Dr.Is going to continue to take x-rays at 3 and 6 months to see if there is any issues but as of now, he sees no need to have another surgery and remove the wire.¿.Further assessment found "it is definitely a piece of the guide wire about the entire length of the acl graft.The entire piece is intact".This report is being raised due to the reported injury of a retained foreign body, whose device origin cannot be confirmed.The 8820, anatomic acl disposable kit will be listed as a concomitant device, and allegations against it reported separately.
Event or Problem Description
A sales representative reported on behalf of a customer that the c8006d, guidewire,nitinol 14 in,sterile device was used in an acl reconstruction procedure on (b)(6)2024 and post-operatively, on (b)(6)2024, the doctor ¿took post op x-rays of the patient and realized that one of our guide wires for our screws is still in the patient, embedded in the autograft.We are not positive if it is the guidewire from the 8820 acl kit (lot 1422285) or the c8006d guidewire (lot 1183654), both were opened in the case.The patient has no pain or issues at the moment the wire was found during a routine post op x-ray.Dr (b)(6) is going to continue to take x-rays at 3 and 6 months to see if there is any issues but as of now, he sees no need to have another surgery and remove the wire.¿.Further assessment found "it is definitely a piece of the guide wire about the entire length of the acl graft.The entire piece is intact".This report is being raised due to the reported injury of a retained foreign body, whose device origin cannot be confirmed.The 8820, anatomic acl disposable kit will be listed as a concomitant device, and allegations against it reported separately.
Additional Manufacturer Narrative
The device will not be returned, and no photographic evidence was provided.Therefore, a device malfunction cannot be verified.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 (b)(4) device for this lot number and failure mode.A two-year review of complaint history revealed there has been a total of (b)(4) reports, regarding (b)(4) devices, for this device family and failure mode.During this same time frame (b)(4) 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 (b)(4).Per the instructions for use, the user is advised to 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 per regulatory requirements to help ensure patient safety.

• Brand Name: BIOSCREW HYPERFLEX
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer (Section G): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer Contact: beth madeline ; 11311 concept blvd; largo, FL 33773 ; 7274708358
• MDR Report Key: 21167534
• Report Number: 1017294-2025-00005
• Device Sequence Number: 4273097
• Product Code: MDM
• UDI-Device Identifier: 10845854041697
• UDI-Public: (01)10845854041697(17)260805(10)1183654
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 02/06/2025

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 Expiration Date: 08/05/2026
• Device Catalogue Number: C8006D
• Device Lot Number: 1183654
• 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: 12/26/2024
• Supplement Date Received by Manufacturer: 02/03/2025
• Initial Report FDA Received Date: 01/16/2025
• Supplement Report FDA Received Date: 02/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: (B)(6), ANATOMIC ACL DISPOSABLE KIT.; (B)(6), ANATOMIC ACL DISPOSABLE KIT.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 39 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic