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

Catalog Number UNAVAILABLE

Device Problems Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Joint Disorder (2373); Patient Problem/Medical Problem (2688)

Event Type  Injury  

Manufacturer Narrative

This is the final report submitted regarding this surgical event and medical device.The information contained in this report is being provided to the fda to comply with regulations regarding medical device reporting and is based on information submitted by others that may or may not be factually correct.This submission does not constitute a determination or admission that a device has malfunctioned or is related to a death or injury.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 a recurrent deformity (no revision surgery).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: 8970897
• MDR Text Key: 156789758
• Report Number: 3004983210-2019-00046
• 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

• Date FDA Received: 09/06/2019
• 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
• Date Manufacturer Received: 08/15/2019
• 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