MAUDE Adverse Event Report: KINAMED, INC. SUPERCABLE ISO-ELASTIC SYSTEM; CERCLAGE FIXATION,

Catalog Number 35-100-1010

Device Problem Use of Device Problem (1670)

Patient Problems Unspecified Infection (1930); Injury (2348); Patient Problem/Medical Problem (2688)

Event Type  Injury  

Manufacturer Narrative

To date, over 120,000 super cable iso-elastic cerclage implants have been used since the product was introduced in 2004.This is the first report of a bone reaction as described.The super cable system has a long history of successful use with an extremely low adverse event rate.Inspection of the explanted super cables was not possible because they were discarded and not available for return.The lot number(s) were not reported.Review of the device history records was not possible because the lot number information is not available at this time.Review of the super cable cerclage system labeling and risk analysis confirms that the cautions, warnings, and adverse effects relating to the potential for infection, tissue reaction, and compromised tissue integrity are appropriately described.The super cable's instructions for use and surgical technique guide (documents b00109h and b00110j, respectively) include statements about proper handling, precautions about over-tensioning which can create potential for the cable to cut into bone, and statements that final tension depends on the surgeon's tactile and clinical assessment of bone quality and bone reduction and that over-tensioning could result in the cable damaging the bone.The event details including anonymized radiographs were shared with a highly experienced hip surgeon for consultation.The consulting surgeon stated that a larger fracture callus is explained by high cable tension but he knows of no mechanism whereby the cable would contribute to the observed bone reaction.The consulting surgeon stated that slowly progressing indolent infections are not infrequent in this type of fracture surgery involving sub-trochanteric nails, because the nails are very stiff and tend to cause stress shielding of the surrounding bone which can compromise the healing, and that such infections, including osteomyelitis, can show up a couple of years after the surgery and appear as the described scalloping.The consulting surgeon concluded that these cases involved indolent infection which led to osteomyelitis and subsequent nonunion or bone resorption around the hardware.He stated that it is not uncommon to see hypertrophic callus with a subtle nonunion underneath, and little pain, where the subtle nonunion zone can get infected due to micromotion.A literature search (citations referenced below) confirmed that nonunion and infection are known complications associated with nail fixation for subtrochanteric fractures.The supercable system has 15 years of clinical experience in orthopedic applications, including in challenging cases that involve poor bone quality, with no evidence of an elevated risk for the type of bone reaction reported.The exact root cause has not been determined at this time.Should additional information become available, the root cause investigation will be reopened.Based upon the information in this investigation, there is no further corrective action or preventive action because the cautions, warnings, and adverse effects are appropriately described in the instructions for use and surgical technique.References: jackson et al (2018) management of subtrochanteric proximal femur fractures: a review of recent literature.Advances in orthopedics.Hindawi article id 1326701.Dziadosz (2015) considerations with failed intertrochanteric and subtrochanteric femur fractures.Journal of orthopedic trauma 29(4): s17-s21.

Event Description

On 09/16/2019, a us sales representative reported that an orthopedic trauma surgeon had concerns with the 1.5 mm super cable iso-elastic cerclage implant.The surgeon was contacted and reported a few femur fracture cases involving sub-trochanteric nail (brand/manufacturer not reported) fixation in which the fracture had healed as expected and patient was doing fine through the healing period, but 1-2 years later presented with a "bone reaction" (which he described as delayed scalloping of the bone around/under the cables, some with infection).In these cases, the hardware was explanted and the situation resolved.The explanted cables were not saved.The surgeon also stated that he has observed continuing callus formation around the cables.The surgeon did not report the exact number of cases or other requested inquiry details.This report is for these reported events because the number of patients involved is unknown at this time.The surgeon indicated that he always tensions the cable to at least the hi mark and often goes past hi with a goal of maximizing cable tension, and that these patients had a mixture of femur bone quality.The surgeon stated that over-compression from his technique could be the cause.

• Brand Name: SUPERCABLE ISO-ELASTIC SYSTEM
• Type of Device: CERCLAGE FIXATION,
• 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: 9192090
• MDR Text Key: 162653422
• Report Number: 2027148-2019-00002
• Device Sequence Number: 1
• Product Code: JDQ
• UDI-Device Identifier: 00898142001357
• UDI-Public: 00898142001357
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K030256
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 35-100-1010
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/16/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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