MAUDE Adverse Event Report: TORNIER INC CANNULINK FIXATION SYSTEM; INTRAOSSEOUS FIXATION SYSTEM

Catalog Number UNAVAILABLE

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

Patient Problems Embolus (1830); Pain (1994); Patient Problem/Medical Problem (2688)

Event Type  Injury  

Manufacturer Narrative

This is the final report submitted regarding this surgical event and medical device.The source of this report is literature: article: seth h.Richman, md , marcelo bogliolo piancastelli siqueira, md , kirk a.Mccullough, md , and mark j.Berkowitz, md , correction of hammertoe deformity with novel intramedullary pip fusion device versus k-wire fixation.Foot & ankle international® 2017, vol.38(2) 174-180.Doi: 10.1177/1071100716671883.

Event Description

It was reported in a 2017 journal from richman, et al., out of three patients not satisfied with the outcome from the implanted cannulink device, one patient developed crps in the foot, a calf dvt, and a nonfatal pulmonary embolus (was later subsequently diagnosed with pancreatic cancer).Source - article: seth h.Richman, md , marcelo bogliolo piancastelli siqueira, md , kirk a.Mccullough, md , and mark j.Berkowitz, md , correction of hammertoe deformity with novel intramedullary pip fusion device versus k-wire fixation.Foot & ankle international® 2017, vol.38(2) 174-180.Doi: 10.1177/1071100716671883.

• Brand Name: CANNULINK FIXATION SYSTEM
• Type of Device: INTRAOSSEOUS FIXATION SYSTEM
• Manufacturer (Section D): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer Contact: mary mcnabb ; 4375 e park 30 drive; columbia city, IN 46725 ; 5743713153
• MDR Report Key: 8970898
• MDR Text Key: 161039930
• Report Number: 3004983210-2019-00045
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120165
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/06/2019

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: Lay User/Patient
• Device Catalogue Number: UNAVAILABLE
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/15/2019
• Initial Date FDA Received: 09/06/2019
• 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): Disability