MAUDE Adverse Event Report: CONMED LARGO GENESYS CROSSFT, HI-FI; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number	CFBC-5502
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the device, cfbc-5502, suture anchor with two #2 (5 metric) hi-fi sutures,5.5 mm, was being used during a rc repair procedure on (b)(6) 2024 when it was reported, ¿so, after making pilot hole to insert the anchor, first anchor after screwing got out from the pilot anchor along with the suture and second one broke down upon insertion.¿ further assessment questioning found from the reporter, ¿yes, device got broke during the surgery, and fragment also fell off at the surgical site but it was removed completely with the help of grapser with out any harm.Surgery was completed using sironix titanium metal anchor at the same place.No intervention required, patient was treated as per surgery procedure and discharged as usual.No prolongation of stay due to this.¿ there was no report of injury, medical intervention, or hospitalization for the patient.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional 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.
Event or Problem Description
The customer reported that the device, cfbc-5502, suture anchor with two #2 (5 metric) hi-fi sutures,5.5 mm, was being used during a rc repair procedure on (b)(6) 2024 when it was reported, "so, after making pilot hole to insert the anchor, first anchor after screwing got out from the pilot anchor along with the suture and second one broke down upon insertion." further assessment questioning found from the reporter, "yes, device got broke during the surgery, and fragment also fell off at the surgical site but it was removed completely with the help of grapser with out any harm.Surgery was completed using sironix titanium metal anchor at the same place.No intervention required, patient was treated as per surgery procedure and discharged as usual.No prolongation of stay due to this." there was no report of injury, medical intervention, or hospitalization for the patient.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
The device will not be returned for evaluation, but photographic evidence has been provided.Root cause cannot be determined, however, based ifu; a possible cause of this event could be lateral loading.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.(b)(4).Per the instructions for use, the user is advised that preoperative and operating procedures, including knowledge of surgical techniques and proper selection and placement of the implant are important considerations in the successful utilization of this device.Surgeon must choose proper implant size based on specific procedure and patient history.Inspect all instruments for damage prior to use.Ensure the anchor is properly seated on the driver tip prior to and during implantation.Ensure the free ends of the suture securely fit into the suture retaining mechanism on the driver handle and that the sliding door is closed (if applicable).Avoid lateral loading while inserting the genesys crossft suture anchor.Maintain proper alignment during insertion of the anchor and disengagement of the driver.For a trans-tissue approach the anchor must be rotated, as opposed to pushed, through the tissue to prevent tearing.We will continue to monitor for trends through the complaint system to assure patient safety.

• Brand Name: GENESYS CROSSFT, HI-FI
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, 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: john berga ; 11311 concept blvd; largo, FL 33773 ; 7273995358
• MDR Report Key: 20770569
• Report Number: 1017294-2024-00139
• Device Sequence Number: 15499291
• Product Code: MAI
• UDI-Device Identifier: 20845854026783
• UDI-Public: (01)20845854026783(17)241215(10)1213793
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K101100
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2025

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 Expiration Date: 12/15/2024
• Device Catalogue Number: CFBC-5502
• Device Lot Number: 1213793
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2024
• Supplement Date Received by Manufacturer: 12/26/2024
• Initial Report FDA Received Date: 11/25/2024
• Supplement Report FDA Received Date: 01/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SIRONIX TITANIUM ANCHOR; SIRONIX TITANIUM ANCHOR
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic