MAUDE Adverse Event Report: CONMED Y-KNOT RC ANCHOR WITH TAPE, ONE 2MM WHITE/BLACK HI-FI TAPE, ONE NO.2 (5 METRIC)

Catalog Number	YRC02STB
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The used device was returned to conmed for evaluation.Visual inspection found one of the shaft tips was broken off, the broken piece was not returned for evaluation.The driver was also found to be slightly bent.This is a technique dependent device.A review of the manufacturing documents verified the device was produced per current and approved procedures and material specifications.Non-conformances regarding the product's identity, quality, safety, effectiveness or performance were not identified at the time of manufacture.A review of this lot number showed no other complaint for this lot product and event description.A two-year review of complaint history revealed no other similar complaints for this product family and failure mode.(b)(4).The instructions for use advises the user of the following.Inspect instruments prior to use to ensure they are in good physical condition and function properly.There should be no loose, broken or misaligned parts.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 lateral loading while inserting y-knot anchors.Maintain proper alignment during insertion of anchors and disengagement of drivers.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
The user facility reported that during a shoulder procedure, a prong of the driver of the yrc02stb broke off.The piece was retrieved and there were no reported surgical delays or patient injury.Although multiple attempts have been made, no additional information regarding patient status or procedure has been provided.This report is being raised on the basis of a reported malfunction with potential for injury with recurrence.

• Brand Name: Y-KNOT RC ANCHOR WITH TAPE, ONE 2MM WHITE/BLACK HI-FI TAPE, ONE NO.2 (5 METRIC)
• Common Device Name: Y-KNOT RC ANCHOR WITH TAPE, ONE 2MM WHITE/BLACK HI-FI TAPE, ONE NO.2 (5 METRIC)
• Manufacturer (Section D): CONMED; 11311 concept blvd.; largo FL 33773
• MDR Report Key: 7519610
• Report Number: 1017294-2018-00061
• Device Sequence Number: 1176173
• Product Code: MBI
• UDI-Device Identifier: 10845854044735
• UDI-Public: (01)10845854044735(17)230215(10)905821
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K131035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/16/2018

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: 02/15/2023
• Device Catalogue Number: YRC02STB
• Device Lot Number: 905821
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2018
• Initial Report FDA Received Date: 05/16/2018
• Patient Sequence Number: 1