MAUDE Adverse Event Report: CONMED Y-KNOT RC ALL-SUTURE ANCHOR; Y-KNOT ANCHOR

Catalog Number	YRC02
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported device was discarded by the user facility; therefore, a packaging evaluation is not able to be completed.The alleged sterility breach is unable to be verified.No prior complaints have been filed against this lot.In the past two years, one similar complaint has been reported for this device family.In this same timeframe, (b)(4).This reported packaging issue was obvious to the facility, prompting the disposal of the device.There was no patient involvement.As with all medical devices, examination of the product occurs multiple times prior to use.Good clinical practice would include examination and verification of the original packaging and its labeling to ensure both are intact.The instructions for use (ifu) provides the following warning.-if packaging has been opened/damaged or altered, do not use the product and contact the manufacturer immediately.This incident type will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
A sterility breach was reported on a yrc02 anchor.This was found during inspection; therefore, there was no patient contact.Additional information was collected from the sales representative that the anchor came in a box of 10 and seemed to have a crease in it as if it had been folded during shipment.There was no obvious breach of sterility, however, this device was discarded and not used due to uncertainty.This report is raised on the basis of a reported device malfunction with potential for injury with recurrence.

• Brand Name: Y-KNOT RC ALL-SUTURE ANCHOR
• Common Device Name: Y-KNOT ANCHOR
• Manufacturer (Section D): CONMED; 11311 concept blvd; largo FL 33773
• MDR Report Key: 6940025
• Report Number: 1017294-2017-00092
• Device Sequence Number: 788059
• Product Code: MBI
• UDI-Device Identifier: 10845854080542
• UDI-Public: (01)10845854080542(17)220603(30)1(10)840628
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K133224
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/11/2017

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: No Information
• Device Expiration Date: 06/03/2022
• Device Catalogue Number: YRC02
• Device Lot Number: 840628
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2017
• Initial Report FDA Received Date: 10/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1