MAUDE Adverse Event Report: TORNIER INC PITON FIXATION IMPLANT SYSTEM; PITON, 3.5MM

Catalog Number SMK000101

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem No Code Available (3191)

Event Date 06/03/2019

Event Type  malfunction  

Manufacturer Narrative

This is the final report submitted regarding this surgical event and medical device.

Event Description

It was reported that for a case on (b)(6) 2019 that 4 out of the 5 pitons used "pulled out" and did not fixate to bone.(all same lot #).This caused surgery to be delayed by 1.5 hrs.The surgeon used a bone tunnel to get the fifth piton to implant.No other effects were noted due to this issue.

• Brand Name: PITON FIXATION IMPLANT SYSTEM
• Type of Device: PITON, 3.5MM
• 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: 8709019
• MDR Text Key: 148558999
• Report Number: 3004983210-2019-00027
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091870
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/05/2022
• Device Catalogue Number: SMK000101
• Device Lot Number: AH51216
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/06/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2019
• 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): Required Intervention