MAUDE Adverse Event Report: CONMED LINVATEC GRAFTMAX BUTTON ALB (ADJUSTABLE LOOP BUTTON); FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number KS-ALB

Device Problems Migration or Expulsion of Device (1395); Positioning Problem (3009)

Patient Problem No Information (3190)

Event Date 09/04/2015

Event Type  Injury  

Manufacturer Narrative

On 17-sep-2015 conmed received the graftmax button alb for evaluation.A visual examination of the returned implant found that the suture loop was frayed.It is possible that the observed fraying was caused when the explanted button was re-threaded prior to being returned for analysis.The surgeon has been in-serviced to assure understanding of proper technique when using this device.The surgeon suggested during in-service that he should mobilize the knee more before cutting the suture flush with the skin.This is a new device first released in mar-2015 and it is currently being monitored by new product quality engineering.A review of the device history record (dhr) for lot 646575 shows the lot (b)(4) and was manufactured on 06-may-2015 in a lot of (b)(4) units.The dhr showed no discrepancies during manufacturing that could have caused or contributed to this alleged problem.Since the release of this product family in 2015, there have been no (0) other complaints for this device.To date, there has been only one (1) other complaint received for all devices in this product family.As at 08-sep-2015, a total of (b)(4) units have been supplied worldwide.The use of this product is technique dependent.The instructions for use (ifu) provides the user with the following contraindication: conditions which tend to limit the patient's ability or willingness to follow directions during the healing period.The instructions for use (ifu) provides the user with the following warnings and precautions: preoperative and operating procedures, including knowledge of surgical techniques and proper selection and placement of the implant, are important considerations in the successful utilization of this fixation device.It is recommended that interference screws and related insertion instrumentation be available in the event of complications during implantation.Any decision to remove the fixation device during a second procedure must take into consideration the potential risk to the patient of an additional surgical procedure.Implant removal must be followed by adequate postoperative management.Detailed instructions on the use and limitations of the device must be given to the patient.

Event Description

The user facility reported that a routine acl reconstruction was performed (b)(6) 2015 using a conmed kls-alb graftmax button (adjustable loop button).On (b)(6) 2015 a patient follow-up x-ray indicated the product button had migrated away from the graft into the quadriceps.As a result of the migration, a 2nd surgery was conducted on (b)(6) 2015 to retrieve the button.It was reported that the initial graft was still in place and functioning but needed to be secured.The retrieved graftmax button's suture loop was found to be undone when it was examined.A new interference screw was placed to secure the graft in the femoral condyle.The surgery was completed successfully using the same incision sites as were used in the initial acl reconstruction surgery.

• Brand Name: GRAFTMAX BUTTON ALB (ADJUSTABLE LOOP BUTTON)
• 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: 5105142
• MDR Text Key: 26807602
• Report Number: 1017294-2015-00045
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K070780
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Report Date: 09/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/30/2016
• Device Catalogue Number: KS-ALB
• Device Lot Number: 646575
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/04/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/06/2015
• 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
• Treatment: 5MM XO BUTTON BRILL BIT, ITEM #C8590, LOT# UNKNOWN
• Patient Outcome(s): Required Intervention
• Patient Age: 20 YR