MAUDE Adverse Event Report: CONMED LINVATEC Y-KNOT RC ALL-SUTURE ANCHOR; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number YRC03

Device Problems Break (1069); Device Or Device Fragments Location Unknown (2590)

Patient Problems Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)

Event Date 03/19/2014

Event Type  Injury  

Event Description

The customer reported that during use of the y-knot rc all suture anchor in a right rotator cuff repair procedure on (b)(6) 2014, one of the inserter/driver tines broke off and was left buried in the patients bone.It was suggested by the rep (who was present during the procedure), that the surgeon use a "punch" to create a pilot hole before inserting the y-knot rc anchor.However, the surgeon declined and attempted to insert the anchor without the punch.The inserter/driver was removed after malleting, but the anchor was still attached to the inserter, and it was noted that one of the two inserter tines was missing.The surgeon was asked if he wanted to bring in intraoperative fluoroscopy to look for the inserter tine, but the surgeon declined, stating that the tiny metal fragment was affixed in the patient¿s bone.The surgeon proceeded to insert two (2) additional y-knot rc anchors, using the recommended "punch" before inserting these anchors.No further complications or injury to the patient was noted, and the procedure was completed as intended.

Manufacturer Narrative

On (b)(4) 2014 conmed received a "used" y-knot rc inserter/driver for evaluation.Visual inspection of the driver found one of the "tines" had broken off and confirmed the reported breakage.In this instance, it was reported that the surgeon elected not to use of the associated "punch" to create a pilot hole before insertion of the anchor.Based on this finding, it is believed that the most likely cause of the driver breakage is user related, and a probable result of misuse.The product's instructions for use advises the user: in hard bone situations, advance the appropriate 2.8mm bone punch or drill bit into the bone until the laser line is flush with the surface of the bone.This lot was manufactured on january 22th, 2014 in a lot of (b)(4) units.A review of the device history record showed there were no anomalies noted during the manufacturing of the device which would have caused the reported breakage.Additionally, there were no other complaints received for this item and lot number combination.This failure mode is addressed in the device's risk document, and the safety risk has been evaluated to be acceptable.This is a newly released device, which is very technique dependent.Knowledge of surgical techniques and proper selection and placement of the implant are important considerations in the successful utilization of this device.To reduce the risk of tip breakage and injury to the patient, the product's instructions for use (ifu) provides the following precautions: exercise care in the use of the device to minimize side and/or bending loads.Do not use excessive force on instruments to avoid damage or breakage during use.

• Brand Name: Y-KNOT RC ALL-SUTURE ANCHOR
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): CONMED LINVATEC; 11311 concept blvd.; largo FL 33773
• Manufacturer (Section G): CONMED LINVATEC; 11311 concept blvd.; largo FL 33773
• Manufacturer Contact: brenda johnson ; 11311 concept blvd.; largo, FL 33773 ; 7273995515
• MDR Report Key: 3749377
• MDR Text Key: 4547684
• Report Number: 1017294-2014-00012
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/19/2014

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
• Device Operator: Physician
• Device Expiration Date: 07/21/2015
• Device Catalogue Number: YRC03
• Device Lot Number: 521265
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/19/2014
• Initial Date FDA Received: 04/14/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/22/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 42 YR