MAUDE Adverse Event Report: CONMED Y-KNOT RC ALL-SUTURE ANCHOR, WITH TWO NO. 2 ( 5 METRIC) HI-FI SUTURES

Catalog Number	YRC02
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/10/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported driver was not returned to conmed for evaluation; therefore, this alleged product failure is unable to be verified.The most probable cause for this breakage is excessive force applied on the device during use.A review of the manufacturing documents has verified the devices were produced per current and approved procedures and material specifications.Non-conformances regarding the product's identity, quality, safety, effectiveness or performance were not identified during manufacture that would contribute to this issue.A two-year historical complaint review revealed one similar complaint for this device family.In that same timeframe, (b)(4) devices have been manufactured and shipped worldwide, making the rate of occurrence of this failure (b)(4) percent.A risk analysis was performed and found acceptable.The instructions for use advise the user of the following.Inspect all instruments prior to use to ensure that are in good physical condition and function properly.There should be no loose, broken or misaligned parts.Exercise care in the use of these devices to minimize side or bending loads.Do not use excessive force on instruments to avoid damage or breakage during use.Avoid unintended contact with other surgical instruments during use to prevent damage or breakage.This incident type will continue to be monitored within the complaint system to assure patient safety.
Event or Problem Description
This incident was reported to conmed on (b)(4) 2016 and deemed nonreportable on 31-oct-2016.On 08-jan-2018, a historical complaint review was pulled for this product code and this incident was reassessed.A customer reported during an arthroscopic shoulder surgery, an anchor broke and a tip was left in the pilot hole.The surgeons could not retrieve this "tip" as the patient's bone was hard.The procedure was completed using an alternative device.No patient injury was reported.This incident has been deemed reportable on the basis of a device malfunction where a non-implantable device component remained in the patient.

• Brand Name: Y-KNOT RC ALL-SUTURE ANCHOR, WITH TWO NO. 2 ( 5 METRIC) HI-FI SUTURES
• Common Device Name: Y-KNOT RC ALL-SUTURE ANCHOR
• Manufacturer (Section D): CONMED; 11311 concept blvd; largo FL 33773
• MDR Report Key: 7210530
• Report Number: 1017294-2018-00006
• Device Sequence Number: 16390629
• Product Code: MBI
• UDI-Device Identifier: 10845854080542
• UDI-Public: (01)10845854080542(17)210510(30)1(10)748403
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K133224
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/22/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/10/2021
• Device Catalogue Number: YRC02
• Device Lot Number: 748403
• 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: 01/08/2018
• Initial Report FDA Received Date: 01/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 52 YR