MAUDE Adverse Event Report: CONMED CORPORATION Y-KNOT FLEX, 1.3MM, DISPOSABLE DRILL BIT; BIT, SURGICAL

Catalog Number Y13D

Device Problem Material Fragmentation (1261)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/24/2021

Event Type  malfunction  

Manufacturer Narrative

Additional information: the patient's weight was advised to be (b)(6); however, the reporter did not report if this was pounds or kilograms; therefore, it is not listed in a4 since the designation of what type of weight would be required.Manufacturer narrative: the reported device is being returned to conmed for evaluation.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

The sales representative reported on behalf of the customer that the y13d device was being used during a shoulder labrumfixation on (b)(6) 2021 when it was reported "during driving the metal peak of the anchor was broken.All parts were retrieved".This caused a 30-minute delay in the procedure.The procedure was completed with an alternate device.Further assessment questioning found that the disposable dill bit is what was broken and retrieved.There was no report of injury, medical intervention, or hospitalization for the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

Examination of the returned used, item y13d found device slightly bend and broken wire.Broken wire was returned.Examination performed per print y13d, could not find any issues per critical dimensions.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 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.(b)(4).Per the instructions for use, the user is advised that prior to use, remove all protective packaging and tip protector, if applicable.Inspect instruments prior to use to ensure they are in good physical condition.There should be no loose, broken or misaligned parts.Inspect instruments after use to ensure they have not been damaged.Do not use excessive force on instruments to avoid damage or breakage during use.Do not use instruments to pry, as bending or breakage may occur.Exercise care when using the drill bits and drill guide.Applying side or bending loads may cause drill bit breakage, oversized tunnel or generation of metal particulates.Use appropriate drill guide to avoid drill bit breakage or damage.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: Y-KNOT FLEX, 1.3MM, DISPOSABLE DRILL BIT
• Type of Device: BIT, SURGICAL
• Manufacturer (Section D): CONMED CORPORATION; 11311 concept blvd.; largo FL 33773
• MDR Report Key: 11540812
• MDR Text Key: 245808234
• Report Number: 1017294-2021-00142
• Device Sequence Number: 1
• Product Code: GFG
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/22/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 02/04/2024
• Device Catalogue Number: Y13D
• Device Lot Number: 997725
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2021
• Initial Date Manufacturer Received: 03/03/2021
• Initial Date FDA Received: 03/22/2021
• Supplement Dates Manufacturer Received: 04/05/2021
• Supplement Dates FDA Received: 04/22/2021
• Patient Sequence Number: 1
• Patient Age: 52 YR