MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA CADENCE IMPLANT-UNSPECIFIED; CADENCE TOTAL ANKLE SYSTEM|

Catalog Number XXX-CADENCE IMPLANT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bone Fracture(s) (1870)

Event Date 11/14/2016

Event Type  Injury  

Manufacturer Narrative

Integra completed its internal investigation 20dec2016.The investigation included: method: - review of device history records.- review of complaint management database for similar complaints.Results: the product id and lot number were not provided.The complaint report does not include the device lot number; therefore, a dhr review could not be conducted.A review of the complaint records for the same product (or similar products within the product family) for the alleged hazardous situation/failure mode received, determined three complaints of fractured tibial trays have been received during the lifetime of the product.Complaint rate: total # complaints = 6 number of procedure = 117 procedures complaint rate = 6/103*100 = 5.1%.Conclusion: the device was not returned to integra for evaluation.The most probable root cause for the presence of a tibial posterior fracture is when the implant is inserted and impacted at an angle resulting in the fins fracturing the bone.A corrective action has been initiated to determine root cause and develop a corrective action plan.

Event Description

It was reported the patient suffered a tibia fracture intraoperatively.¿this case went without a hitch- mostly.We did recognize a posterior tibia fracture that was not related to the tibia component.¿ description of implantation procedure was reported: size 2 tibia, size 2 6 mm insert ,size 2 talus.The slope and resection was confirmed with the angel wing.This was changed to confirm a 4 degree slope for the actual cut.The posterior chamfer guide position was noted with a perfect lateral.You can see in the posterior edge of the tibial cut ¿ a piece left over from the tibial resection.This was critical to the case.This was not appreciated at this point.This is bone leftover from the initial resection.This was not noticed until we trialed with the tibial component.When dr.(b)(6) inserted the tibial trial ¿ 2x it pushed the fragment out from the distal tibial (i apologize but i do not have pictures).A size 2 tibial trial was chosen.This kept pressure off of the posterior fragment.We took time to take x- rays of the bad toe in technique and the new technique of parallel insertion position.Very slight anterior tibial overhang was noted on the anterior medial portion of the component but it was not for the entire width of the tibial component.It was reported no patient injury is alleged.It was reported the fracture was not related to the tibia component (device).

• Brand Name: CADENCE IMPLANT-UNSPECIFIED
• Type of Device: CADENCE TOTAL ANKLE SYSTEM|
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; 4900 charlemar drive; cincinnati OH 45227
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; cincinnati OH 45227
• Manufacturer Contact: maria leonard ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 6200017
• MDR Text Key: 63179027
• Report Number: 1651501-2016-00048
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• PMA/PMN Number: K151459
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Dental Hygienist
• Type of Report: Initial
• Report Date: 12/02/2016

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 Catalogue Number: XXX-CADENCE IMPLANT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/02/2016
• Initial Date FDA Received: 12/22/2016
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other