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

Catalog Number YRC02

Device Problems Loose or Intermittent Connection (1371); Device Slipped (1584)

Patient Problems Pain (1994); Swelling (2091); Skin Tears (2516)

Event Date 08/20/2014

Event Type  Injury  

Event Description

The customer reported that the y-knot rc all-suture anchor was used during a mini-open rotator cuff repair procedure on (b)(6)-2014.As reported, approximately 4-6 weeks after the surgery, the patient presented with signs of pain and swelling in the shoulder and the patient was followed for this condition for several months.After a repeat mri, which revealed a recurrent full thickness rotator cuff tear and this prompted the surgeon to perform a revision surgery on (b)(6)-2014 to repair the recurrent full thickness tear.Follow-up with the surgeon learned that it was during this second surgery that the surgeon noted the "y-knot anchor might have slipped through the patient's osteoporotic bone and became more prominent.The suture was loosened because the y-knot anchor had allegedly moved up in the pilot hole".It was further reported by the surgeon that there was no indication that there was any creeping occurred when the anchor was set, as it was tested and pulled to be certain that it did not pull free during the initial surgery.The surgeon did indicate that the patient presented with osteoporotic bone, and the need to use an additional, like-device to repair the patient's rotator cuff repair during the initial procedure.Other received information indicated that during the recovery period the patient was immobilized in a sling after surgery and given continuous passive motion therapy (cpm).However, the length of the recovery period was not provided.To date, there has been no additional information received regarding the patient latest condition or any indication that a long term adverse effect has occurred.

Manufacturer Narrative

As reported, the "used" y-knot rc all-suture anchor from the surgery on 30-apr-2014 is not expected for evaluation, as it was disposed of at the user facility after the revision surgery.Without the involved device, an evaluation could not be performed and/or determine the root cause of the alleged "implant migrating".This lot was manufactured on 10-apr-2014 in a lot of (b)(4).A review of the device history record showed, there were no anomalies or nonconformances noted during the manufacturing process that could have caused or contributed to the reported complaint.There were no other similar complaints received for this item and lot number combination.In addition, a two-year review of the device complaint history showed other than this alleged incident, there have been no serious injuries or deaths reported related to any item in this product family regarding "implant migrating".Based on all available information, this reported incident appeared to be isolated.This failure mode is addressed in the device's risk document, and the safety risk has been found 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.The surgeon must choose proper implant size based on specific procedure and patient history.To reduce the risk of injury to the patient, the product's instructions for use (ifu) provides the following warnings and precautions: -any decision to remove the device should take into consideration the potential risk to the patient of a second surgical procedure.-y-knot all suture anchors have not been tested for heating or migration in the mri environment.-use of sutures other than indicated may result in loss of fixation.-do not use this device in physical conditions that would eliminate, or tend to eliminate adequate implant support, or retard healing.-do not use this device in conditions which tend to limit the patient's ability or willingness to restrict activities or follow directions during the healing and rehabilitation period.Device discarded after the procedure.

• 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: 4418004
• MDR Text Key: 14878306
• Report Number: 1017294-2015-00005
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 133224
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/16/2014

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: 03/31/2019
• Device Catalogue Number: YRC02
• Device Lot Number: 547085
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/16/2014
• Initial Date FDA Received: 01/14/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/10/2014
• 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): Required Intervention
• Patient Age: 54 YR