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

Catalog Number 35-100-1010

Device Problems Device Dislodged or Dislocated (2923); Positioning Problem (3009)

Patient Problems Pain (1994); Discomfort (2330); Injury (2348)

Event Date 06/23/2015

Event Type  Injury  

Event Description

Post-operatively, the master distributor reported that the kinamed cable came out of the clasp after it was reportedly locked by the surgeon.The initial surgery (hip arthroplasty) took place on (b)(6) 2015.In this procedure, a kinamed cable was used to reattach the greater trochanter after the greater trochanter was osteotomized to gain access to the femoral canal.The surgeon used a unique cable fixation technique that he had performed five times in the two weeks prior to this case.Three to four days post-operation, the patient experienced mild discomfort around the surgical site.The surgeon confirmed the wedge of the kinamed cable was not pushed into its clasp and the cable was not under tension.On (b)(6) 2015, the kinamed cable was explanted and replaced with a steel wire (manufacturer unknown) that was fixed by a standard surgical knot.Using the unique cable fixation technique, it was explained that the surgeon does not have a clear view of the locking clasp and this may have prevented the surgeon from confirming proper initial locking of the cable clasp.

Manufacturer Narrative

The device was returned for evaluation on 07/20/2015 and device evaluation began immediately.Review of the device history record for this lot of cerclage cables shows they were released with no deviations or non-conformances.As of 07/20/2015, kinamed has not received any other product experience reports for lot k17789.There are no radiographs available for evaluation of this case.

Manufacturer Narrative

Section was incorrectly submitted as (b)(4) , cercalge tensioning instrument (b)(6) 2015.It should be (b)(4), cercalge tensioning instrument (b)(6) 2015.

Manufacturer Narrative

Our inspection of the returned implant observed side-to-side movement of the wedge inside the clip (new unused clasps display no movement between wedge and clip).Also, the wedge was found to be protruding out from the rear of the clip by a distance that is significantly less than the distance defined by our manufacturing specification.There is no evidence that the wedge was ever fully deployed.Together, these findings confirm that this wedge had been partially, but never fully, inserted into its clip.The clip and wedge were further evaluated for any signs of damage or anomalies, none of which were found.The items were functionally tested and worked as expected.The wedge was then fully removed from the clip and visually inspected for damage, which there was none.The wedge shape and other key dimensions were measured and found to be within specification.The wedge and clip were within acceptance specifications.We have determined that the most likely root cause is that limited visibility (due to the position of the clasp at the time of implantation) did not allow the surgeon to fully deploy the wedge and confirm that it was locked.Note that the surgical instructions state to maintain engagement and proper coplanar alignment between the tensioning instrument and the clasp.When visibility of the clasp is limited, we suggest that the surgeon should palpate for both the proper engagement and alignment of the tensioner and clasp.This will allow the surgeon to confirm that the engagement and alignment with the clasp is correct, even when visibility is limited.

• 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: 4928397
• MDR Text Key: 22058384
• Report Number: 2027148-2015-00001
• Device Sequence Number: 1
• Product Code: JDQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K030256
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor,distributor,foreign
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 06/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 12/28/2017
• Device Catalogue Number: 35-100-1010
• Device Lot Number: K17789
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/03/2014
• 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