MAUDE Adverse Event Report: CONMED LINVATEC Y-KNOT RC ALL-SUTURE ANCHOR, WITH TWO NO. 2 HI-FI SUTURES; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number YRC02

Device Problem Device Slipped (1584)

Patient Problem Post Operative Wound Infection (2446)

Event Date 09/12/2015

Event Type  Injury  

Manufacturer Narrative

One (1) used/damaged yrc02 y-knot rc all suture anchor was received for evaluation on 30-mar-2016.Visual inspection of the returned device found the suture anchor was balled up and frayed.Due to product contamination and the poor condition of the returned device, further evaluation and product analysis could not be performed therefore the exact cause of the alleged postoperative infection and/or allergic reaction resulting in the anchor removal could not be determined and/or verified.This lot with the (b)(4) was manufactured on 26-nov-2014.Of the lot containing (b)(4) units, there have been no other similar complaints received.A review of the device lot history shows, there were no anomalies or non-conformances noted during the manufacturing process that could have caused or contributed to the reported problem.A 2-year review of complaint history shows there has been only one other similar report of "post-operative infection/allergic reaction" received for this device.In this instance, it is believed that the alleged post-op infection might be related to some type of the allergic reactions pertaining to this particular patient.This failure mode is addressed in the dfmea, and the safety risk has been found to be acceptable.The conmed linvatec y-knot rc all suture anchor is manufactured from high strength flat braided suture threaded with either two or three #2 (5 metric) hi-fi suture strands.Y-knot anchors are provided single-use, sterile, and preloaded on disposable drivers.The anchor is composed of hi-fi ultra-high molecular weight polyethylene high strength flat braided suture tape.The suture strands are made from hi-fi non-absorbable braided ultra-high molecular weight polyethylene.The driver shaft/body is stainless steel and the driver handle is composed of polycarbonate.To reduce the risk of injury to the patient, the product's instructions for use (ifu) provides the following precautions: patient should be advised that product materials may cause allergic reactions including but not limited to, foreign body reaction, tissue irritation/inflammation or other allergic reactions.Where material sensitivity is suspected, appropriate tests should be made and sensitivity ruled out prior to implantation.The ifu also advises of potential adverse events which include: infections, both deep and superficial.Allergic reaction, tissue irritation/inflammation and other reactions to device materials.Do not use this device in physical conditions that would eliminate, or tend to eliminate adequate implant support, or retard healing.Any decision to remove the device should take into consideration the potential risk to the patient of a second surgical procedure.

Event Description

On (b)(6) 2016, conmed received a request forwarded by the distributor in hong kong from a surgeon, who requested for assistance from conmed to evaluate the y-knot rc all suture anchor, which was removed from the patient after the implantation due to postoperative infection.Received information indicated that the surgeon would like to know if there is "any material change inside the joint after implant" that could lead to "post-op infection" and if there have been any reports of infection with implanted y-knot rc all suture anchor.Other received information indicated that the all suture anchor was removed from the patient a "few months later" due to an alleged infection after a shoulder arthroscopy rotator cuff repair procedure.The report further indicated that the surgeon commented that "the implant is loose and can be easily pulled out", presumably the comment was made as part of the surgeon's assessment during the removal of the all suture anchor.Despite our good faith efforts to obtain additional information through the distributor, no additional patient/event information received from the involved surgeon and/or end user facility.This includes description of event during the original surgery and/or the revision surgery to remove the y-knot rc all suture anchor.Additionally, no patient's demographic information and no user facility name, address and phone number have been received, to date.If additional information becomes available, a follow-up and final report will be submitted.

Event Description

On 14-apr-2016, conmed received additional information from the end-user via an e-mail from the distributor in (b)(4), which listed (b)(6)-2015 as the date of the original surgery and (b)(6)-2015 as the date of the second surgery to remove the y-knot rc all suture anchor.Other received information indicated that the surgeon was first noticed of the infection/allergic reaction due to "surgical wound swelling, erythema and pain".Subsequently, the surgeon elected to perform a secondary surgical intervention to remove the suture anchor due to "persistent residual shoulder surgical wound pain, swelling and recurrent local abscess formation".The report further described the patient's outcome after the second surgery as "good recovery with no more pain, local swelling or collection".

• Brand Name: Y-KNOT RC ALL-SUTURE ANCHOR, WITH TWO NO. 2 HI-FI SUTURES
• 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: 5551046
• MDR Text Key: 41999587
• Report Number: 1017294-2016-00041
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K133224
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/14/2016

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: Health Professional
• Device Expiration Date: 11/30/2019
• Device Catalogue Number: YRC02
• Device Lot Number: 603023
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/30/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/11/2016
• Initial Date FDA Received: 04/06/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/02/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/26/2014
• 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