MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA CORNER OSTEOTOME; CADENCE TOTAL ANKLE SYSTEM

Catalog Number 10204078

Device Problems Patient-Device Incompatibility (2682); Device Operates Differently Than Expected (2913)

Patient Problem Bone Fracture(s) (1870)

Event Type  Injury  

Manufacturer Narrative

The device involved in the reported incident is not available for evaluation.An investigation has been initiated based on the reported information.

Event Description

It was reported a medial malleolus fracture on the right ankle 6 weeks after the implantation of the device.Additional information has been requested.

Manufacturer Narrative

Additional information received on february 5, 2017: procedure performed - total ankle arthroplasty.Surgeon is not sure if the fracture is a result of a failure of the device, he believes is more likely related to implantation, rather than the device itself.Surgeon anticipate functional problems due to this incident, patient underwent fixation of fracture due to displacement and now has a surgical wound dehiscence.Treatment plan after fracture fixation is with wound issue, plan for irrigation and debridement in one week.Patient was following postoperative instructions.The product will remain implanted.Integra has completed their internal investigation on february 1st 2017.The investigation included: methods: review of device history records.Review of complaints history.Results: the cadence corner osteotome was not returned for investigation.Per information provided by the manager of global medical affairs, based on his conversation with the surgeon, the corner osteotome was difficult to remove.As a result, the doctor engaged in what he called ¿wiggling¿ of the osteotome in order to facilitate its removal.He appeared to indicate that this may have been the precipitating event.Dhr review; a review of the lot record did not show any indications of problems that could have caused or contributed to the complaint.Complaint rate: total # complaints = 3.Number of procedure = 161 procedures as of january 31, 2017.Complaint rate = 3/161*100 = 1.9%.A possible root cause was identified as the design of the corner osteotome, part number 10204078.This device is included in the 1.0 set, which is being replaced by part number 10204079 in the 1.1 set.

• Brand Name: CORNER OSTEOTOME
• 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: sonia irizarry ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 6280063
• MDR Text Key: 65870341
• Report Number: 1651501-2017-00004
• 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: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 10204078
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/16/2017
• Initial Date FDA Received: 01/26/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2015
• 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