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

Catalog Number XXX-CADENCE IMPLANT

Device Problems Device Operates Differently Than Expected (2913); Insufficient Information (3190)

Patient Problems Bone Fracture(s) (1870); Tissue Damage (2104)

Event Type  Injury  

Event Description

It was reported a radiographic review of a de-identified cadence x-ray was performed and suspected of presenting a fracture of the posterior malleolus of the tibia.The treating physician was contacted for confirmation of the fracture but stated that the radiograph did not demonstrate a fracture.On (b)(6) 2016, an integra surgeon consultant was then contacted via email to review the radiograph and to confirm that no fracture was present.The surgeon consultant indicated that the radiograph did in fact demonstrate a fracture.It was reported that although the device was in contact with the patient no patient injury is alleged.No revision or medical intervention was required.There was no delay in surgery.

Manufacturer Narrative

Integra completed its internal investigation 21dec2016.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.The complaint rate was calculated based on the number of devices affected by the hazardous situation or failure mode, over the number of surgeries or units sold during the period of the review.Complaint rate: (b)(4).Six instances of posterior tibia fractures have been identified indicating that an adverse trend is present.A corrective action has been initiated to determine root cause and develop a corrective action.Conclusion: the device was not returned to integra for evaluation.Because only an immediate post-operative x-ray was available, integra cannot definitively determine what caused this fracture.It is possible the fracture was caused during tibial tray insertion and it is possible the fracture was not caused during tibial tray insertion.When integra cannot definitively determine a complaint¿s root cause, its standard practice is to act conservatively and trend this complaint into all possible root causes.

• 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: 6191712
• MDR Text Key: 62912761
• Report Number: 1651501-2016-00047
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 11/22/2016

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?: No
• Initial Date Manufacturer Received: 11/22/2016
• Initial Date FDA Received: 12/20/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/03/2017
• 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