MAUDE Adverse Event Report: CONMED CORPORATION Y-KNOT FLEX 1.3MM SUTURE ANCHOR WITH ONE NO.2 WHITE/BLUE FI-FI SUTURE; FIXATION DEVICE

Model Number	Y1301
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	10/14/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Examination of the returned used device y1301, found inserter shaft bent and has broken one of the openings at the tip.Broken piece was not returned for the evaluation.This is technique dependent device and the most likely cause of this suspected failure is user related.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; 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.A determination for further investigation has been initiated.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
(b)(6) conmed reported on behalf of their facility that the y1301, y-knot suture anchor's inserter was missing the prongs.During an arthroscopic shoulder stabilization on (b)(6) 2019 the scrub nurse checked the y-knots at end of insertion and noted one of the metal prongs was missing.The surgeon was notified.The surgeon continued with the operation and searched for the missing prong.Nothing was found.The nurse manager was informed and requested an x-ray to be done prior to closing.The x-ray was done.The metal prong was identified as being in the patient's bone.The surgeon made an informed decision to leave the prong insitu as an attempt to get it out could cause injury to the patient.The incident was documented in patient's notes and the patient was informed by surgeon.This report is being rasied for patient injury, due to metal fragment being retained in the bone.

• Brand Name: Y-KNOT FLEX 1.3MM SUTURE ANCHOR WITH ONE NO.2 WHITE/BLUE FI-FI SUTURE
• Common Device Name: FIXATION DEVICE
• Manufacturer (Section D): CONMED CORPORATION; 11311 concept boulevard; largo FL 33773
• MDR Report Key: 9279716
• Report Number: 1017294-2019-00143
• Device Sequence Number: 16844421
• Product Code: MBI
• UDI-Device Identifier: 20845854021658
• UDI-Public: (01)20845854021658(17)230619(30)1(10)939084
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K111779
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/19/2023
• Device Model Number: Y1301
• Device Catalogue Number: Y1301
• Device Lot Number: 939084
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2019
• Initial Report FDA Received Date: 11/05/2019
• 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