MAUDE Adverse Event Report: CONMED CORPORATION Y-KNOT FLEX 1.3MM ALL-SUTURE ANCHOR WITH ONE NO. 2 WHITE/BLUE HI-FI SUTURE; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	Y1301
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer complaint that one of the driver tips was broken was confirmed.Visual examination found suture anchor assembly broken off at one of the tips.The other tip was slightly bent.Broken portion was not returned with product for evaluation.It is suspected that the user applied excessive force on the product and broke off the tip.This is a technique-dependent device and the most likely cause of this suspected failure is user-related.Broken tip is approximately 0.070 inches.Examination was performed per design print.Critical dimensions were inspected per print and could not find any discrepancies.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 were found to have met all specifications prior to shipment and found no abnormalities that would contribute to this issue.A two-year lot history review shows this is the only complaint for this lot number and failure mode.A two-year review of complaint history revealed there has been a total of 14 complaints, regarding 16 devices, for this device family and failure mode.During this same time frame 56,592 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 0.0003.The instructions for use (ifu) provides the user with information regarding proper care and use of this device.Conmed encourages the inspection and/or test of all medical equipment prior to use to ensure all devices are functioning as expected.Per the ifu, the user is also advised to 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 issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
On behalf of the customer, the conmed sales representative reported issues with the y-knot flex 1.3mm all-suture anchor with one #2 white/blue hi-fi suture, item # y1301, lot # 989333 that occurred (b)(6) 2019 at chir.Zentrum during a labrum refixation procedure involving a (b)(6) year old male weighing (b)(6) kg.It was reported "during driving the metal peak of the anchor was broken at the fork.The metal piece was removed from the patient without injury." it is indicated that there was no impact or injury to the patient and the procedure was successfully completed using an alternate y1301 but with a 30-minute delay.Additional information obtained indicates that the issue occurred at the end of the procedure while placing the first suture anchor.The metal piece was retrieved with grasping forceps and the physician confirmed that all the pieces were removed.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence (the fragmentation of the device).
Additional Manufacturer Narrative
The report is being submitted to correct the following fields: corrected 510k from k11179 to k111779.The narrative should read "a two-year review of complaint history revealed there has been a total of 14 complaints, regarding 16 devices, for this device family and failure mode.(b)(4).It was originally reported as " a two-year review of complaint history revealed there has been a total of 14 complaints, regarding 16 devices, for this device family and failure mode.(b)(4).The number of shipped units was corrected, however the other information remains unchanged and correct.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: Y-KNOT FLEX 1.3MM ALL-SUTURE ANCHOR WITH ONE NO. 2 WHITE/BLUE HI-FI SUTURE
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): CONMED CORPORATION; 11311 concept blvd; largo FL 33773 4908
• MDR Report Key: 8539490
• Report Number: 1017294-2019-00048
• Device Sequence Number: 399895
• Product Code: MBI
• UDI-Device Identifier: 10845854021651
• UDI-Public: (01)10845854021651(17)240103(10)989333
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K111779
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2019

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: 01/03/2024
• Device Catalogue Number: Y1301
• Device Lot Number: 989333
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2019
• Initial Date Received by Manufacturer: 03/25/2019
• Supplement Date Received by Manufacturer: 05/23/2019
• Initial Report FDA Received Date: 04/23/2019
• Supplement Report FDA Received Date: 05/23/2019
• 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
• Patient Weight: 95