MAUDE Adverse Event Report: CONMED CORPORATION Y-KNOT FLEX 1.8MM ALL-SUTURE ANCHOR; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	Y1802A
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event of "suture anchor was inserted outside the pilot hole and one of the inserter tips broke; broken piece found on the floor in or" is inconclusive.The device will not be returned for evaluation and no photographic evidence was provided; therefore, root cause cannot be identified.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.A two-year review of complaint history revealed there has been a total of two complaints, regarding two devices, for this device family and failure mode.During this same time frame (b)(4) devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be (b)(4).Per the instructions for use, the user is advised the following: when removing the driver from pilot hole, pull driver straight out.Do not rotate or oscillate about its axis or breakage of driver tip and/ or anchor may result.Do not use excessive force on instruments to avoid damage or breakage during use this issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
The sales representative reported on behalf of the customer that the y1802a device was being used on (b)(6) 2021 during an anterior talofibular ligament procedure when it was reported that " pilot hole was created in the left fibula.Then, y-knot 1.8 suture anchor was inserted using a mallet.However, y-knot 1.8 suture anchor could not be inserted into the pilot hole.Y-knot 1.8 suture anchor was inserted outside of the pilot hole and one of the tips of the inserter broke.After this incident occurred, the broken piece was searched.X ray image (including live image) was also used to find it.However, it could not be found.After that, it was found on the floor of the operation room.The surgery was completed.Y-knot 1.8 suture anchor was inserted outside of the pilot hole.According to the surgeon, the reason of the breakage of the inserter is a technical error.As y-knot 1.8 suture anchor was inserted with a mallet, the tip of the drill guide slipped".There was no report of injury/impact to the patient.There was a delay of about 20 minutes and the procedure was completed with an alternate same device and a y1802.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: Y-KNOT FLEX 1.8MM ALL-SUTURE ANCHOR
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): CONMED CORPORATION; 11311 concept blvd.; largo FL 33773
• MDR Report Key: 11875558
• Report Number: 1017294-2021-00259
• Device Sequence Number: 13705358
• Product Code: MBI
• UDI-Device Identifier: 20845854041793
• UDI-Public: (01)20845854041793(17)220621(30)1(10)845849
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K131035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/25/2021

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: 06/21/2022
• Device Model Number: Y1802A
• Device Catalogue Number: Y1802A
• Device Lot Number: 845849
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2021
• Initial Report FDA Received Date: 05/25/2021
• Patient Sequence Number: 1