MAUDE Adverse Event Report: CONMED CORPORATION YKNOT ONE STEP ANCHOR, ONE #2 HI-FI; FIXATION DEVICE

Catalog Number	Y1S1K
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Examination of the returned used device, item y1s1k found inserter bent at the tip, damage and broken off.Evaluation was performed per print.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.This is the only complaint for this lot number and failure mode within the past two years.(b)(4).Per the instructions for use, the user is advised the following; preoperative and operating procedures, including knowledge of surgical techniques and proper selections and placement of implants are important considerations in the successful utilization of these devices.Surgeon must choose proper implant size based on specific procedure and patient history.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 conmed representative reported on behalf of the facility that the y1s1k, y-not one-step inserter, broke during a bankart arthroscopic shoulder procedure on (b)(6) 2020 on a (b)(6) male.The surgeon attempted to pull the bit from the guide and it would not release.This time the anchor would not pull out though.Looking for a solution, the scrub tech gave the drill some light taps with a mallet, to try and get it to release with no result.After pulling with extreme force the drill bit broke, at the base of the flair near the curved bit portion, leaving roughly 2cm of drill bit sticking out of the glenoid along with the anchor.The representative had them attempt to pull the tails of the anchor and continue pulling with a grasper on the broken bit, which allowed it to finally release.The broken piece was removed.There was no reported delay.There was no reported patient injury.This report is being raised as device malfunction with potential for injury upon reoccurrence.

• Brand Name: YKNOT ONE STEP ANCHOR, ONE #2 HI-FI
• Common Device Name: FIXATION DEVICE
• Manufacturer (Section D): CONMED CORPORATION; 11311 concept boulevard; largo, fl
• MDR Report Key: 9915544
• Report Number: 1017294-2020-00113
• Device Sequence Number: 2764207
• Product Code: MBI
• UDI-Device Identifier: 20845854901844
• UDI-Public: (01)20845854901844(17)210714(10)1074599
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K193606
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/02/2020

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: 07/14/2021
• Device Catalogue Number: Y1S1K
• Device Lot Number: 1074599
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2020
• Initial Report FDA Received Date: 04/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 19 YR