MAUDE Adverse Event Report: KINAMED, INC. SUPERCABLE ISO-ELASTIC SYSTEM; MANUAL SURGICAL INSTRUMENT- PASSER

Catalog Number 38-800-3400

Device Problems Contamination (1120); Microbial Contamination of Device (2303); Device Handling Problem (3265)

Patient Problems Bacterial Infection (1735); Injury (2348)

Event Type  Injury  

Manufacturer Narrative

As of 05/15/2017, over (b)(4) supercable iso-elastic cerclage implants have been used since product introduction in 2004.For the sternotomy closure indication, it is estimated that supercables and associated instruments (mini passer and tensioner) have been used in over (b)(4) cases over the last 2 years, and this is the first report of infection that kinamed has received.The supercable system has a long history of successful use with an extremely low adverse event rate.Inspection of the involved supercable implants and mini passers was not possible because they were not available for return and the cable and curved mini passer instrument lots involved in this event are depleted from our inventory.Review of the supercable cerclage system labeling confirms that the cautions and warnings relating to potential infection are appropriately described.The supercable's instructions for use (document (b)(4)) and the passer's surgical technique (document (b)(4)) includes warnings about aseptic technique and recommended steps to avoid contamination.Review of the device history records and sterilization records for these lots of cerclage cables and the curved mini passer shows they were released with no deviations or non-conformances.Two of the cerclage cable lots were sterilized in the same load which has not resulted in any other known infections in the field.There are no radiographs or photos of the infected surgical site available for evaluation of this case.Review of the device history record for the tensioner was not possible because the lot number was not provided.The supercable system has over 10 years of clinical experience in orthopedic applications, including in challenging cases that involved pre-existing infection (as summarized in several peer-reviewed publications), and approximately 2 years of clinical experience in sternotomy closure with no evidence of elevated infection risk.It is suspected that the root cause was not a result of any issue inherent to the cable system.The most likely root cause is that the wound, the implant, or the instrumentation was somehow contaminated in the operating room, which is a general risk inherent to any surgical procedure and use of any surgical device.Note- this report is associated with mdr # 2027148-2017-00001.Device not returned to manufacturer.

Event Description

On (b)(6) 2017, a cardiothoracic surgeon in (b)(6) performed sternotomy closure using five (1.5mm diameter) supercable cerclage implants (part number 35-100-1010) and two supercable curved mini passer instruments (38-800-3400).The surgeon informed the sales agent that the patient developed acute mediastinitis and that a re-do/revision surgery was performed on (b)(6) 2017 in which the supercable implants were explanted and the sternotomy was closed using another company's cerclage system.The outcome of the surgery was successful and the patient is reported to be doing well.The discharge date has been requested.

• Brand Name: SUPERCABLE ISO-ELASTIC SYSTEM
• Type of Device: MANUAL SURGICAL INSTRUMENT- PASSER
• Manufacturer (Section D): KINAMED, INC.; 820 flynn road; camarillo CA 93012 8701
• Manufacturer (Section G): KINAMED, INC.; 820 flynn road; camarillo CA 93012 8701
• Manufacturer Contact: heather neely ; 820 flynn road; camarillo, CA 93012-8701 ; 8053842748
• MDR Report Key: 6575673
• MDR Text Key: 75457972
• Report Number: 2027148-2017-00002
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: 510K EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 07/28/2021
• Device Catalogue Number: 38-800-3400
• Device Lot Number: K19436
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2016
• 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: 35-100-1010,SUPERCABLE,LOT K19665,EXP. 10/28/2019; 35-100-1010,SUPERCABLE,LOT K19867,EXP.12/28/2019; 35-100-1010,SUPERCABLE,LOT K19868,EXP.12/28/2019; 35-800-7000, SUPERCABLE TENSIONER (60 DEGREE)
• Patient Outcome(s): Required Intervention