MAUDE Adverse Event Report: CONMED CORPORATION YKNOT ONE STEP ANCHOR, TWO #2 RIBBONS; FIXATION DEVICE

Catalog Number	Y1S2R
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	03/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device will not be returned for evaluation however the provided photographic evidence exhibits the reported event.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.A two-year review of complaint history revealed there has been 1 complains regarding 2 devices for this device family and failure mode.During the same time frame (b)(4) devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed, the rate of failure would be.(b)(4).Per the instructions for use, the user is advised the following; preoperative and operating procedures, including knowledge of surgical techniques and proper selection and placement of implants are important considerations in the successful utilization of these devices.The surgeon must choose the proper implant based on specific procedure and patient history.To ensure patient safety, the y-knot onestep anchor system shall be used with an appropriate conmed hall large bone handpiece and y-knot onestep guide.Insertion of the y-knot onestep anchor must be used with a y-knot onestep guide; attempting insertion without a guide may result in patient injury.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 y1s2r, yknot one step anchors, qty 2, were used in a sub-pectoral tenodesis on (b)(6) 2020.The doctor reported that both anchors were taking a while to drill into the bone, and that the drill tip may not be sharp enough to go into hard bone.Both anchors did not deploy.The second anchor's drill bit broke off into the first cortex hard bone.A fluoroscopic image was taken to locate the drill tip.The metallic piece is within the intramedullary canal.It's stable in bone at this time and doesn't need to be removed per the surgeon.The surgeon completed the procedure using q-fix anchor after both anchors failed.The surgeon reports the bone robustness was rated 9 out of 10.There was no delay reported and no patient injury reported.This will be report is being raised as patient injury due to the metal fragment remaining in the patient's bone.

• Brand Name: YKNOT ONE STEP ANCHOR, TWO #2 RIBBONS
• Common Device Name: FIXATION DEVICE
• Manufacturer (Section D): CONMED CORPORATION; 11311 concept boulevard; largo, fl
• MDR Report Key: 9915657
• Report Number: 1017294-2020-00157
• Device Sequence Number: 2764208
• Product Code: MBI
• UDI-Device Identifier: 20845854902117
• UDI-Public: (01)20845854902117(17)200128(10)1078177
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K193606
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/26/2021
• Device Catalogue Number: Y1S2R
• Device Lot Number: 1078177
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2020
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 50 YR