MAUDE Adverse Event Report: CONMED LARGO CROSSFT KNOTLESS DT 4.75MM SUTURE ANCHOR; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	CFK-475DT
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The sales representative reported on behalf of the customer that the cfk-475dt was used during a rotator cuff repair on (b)(6) 2021 when it was reported ¿surgeon was inserting cross ft knotless cfk-475dt for lateral row, and tip of anchor broke off.I was present at the case but had stepped out of theatre to find alternative solution as the patient had soft bone and the previous anterior lateral row anchor had pulled out (same one was re-loaded and re-inserted), and the surgeon wanted an alternative.Large, male patient - over 6 foot.¿.It was reported that the fragment was retrieved from the patient.The procedure was completed with an alternate device after a 2-minute delay.There was no report of injury, medical intervention, or hospitalization for the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
The device will not be returned, it was disposed of in a sharps container, however photographic evidence has been provided that confirm the event.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.(b)(4).Per the instructions for use, the user is advised to avoid lateral loading while inserting the suture anchor.Maintain proper alignment during insertion of the anchor and disengagement of the driver.Proper selection and placement of the implant are important considerations in the successful utilization of this device.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: CROSSFT KNOTLESS DT 4.75MM SUTURE ANCHOR
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): CONMED LARGO; 11311 concept blvd; largo FL 33773
• MDR Report Key: 12518047
• Report Number: 1017294-2021-00340
• Device Sequence Number: 17147324
• Product Code: MBI
• UDI-Device Identifier: 10845854606193
• UDI-Public: (01)10845854606193(17)240326(10)1157906
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K163258
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/23/2021

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: 03/26/2024
• Device Model Number: CFK-475DT
• Device Catalogue Number: CFK-475DT
• Device Lot Number: 1157906
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2021
• Initial Report FDA Received Date: 09/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR