MAUDE Adverse Event Report: CONMED CORPORATION CROSSFT KNOTLESS BIOCOMPOSITE 4.75MM SUTURE ANCHOR WITH ONE 2MM HI-FI TAPE; SUTURE ANCHOR FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number CFKB-475STA

Device Problem Defective Component (2292)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/18/2020

Event Type  malfunction  

Event Description

Conmed anchor was defective when md used it.Fda safety report id# (b)(4).

• Brand Name: CROSSFT KNOTLESS BIOCOMPOSITE 4.75MM SUTURE ANCHOR WITH ONE 2MM HI-FI TAPE
• Type of Device: SUTURE ANCHOR FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): CONMED CORPORATION; utica NY 13502 5994
• MDR Report Key: 10465548
• MDR Text Key: 204988703
• Report Number: MW5096319
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/29/2023
• Device Catalogue Number: CFKB-475STA
• Device Lot Number: 1103426
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 103