MAUDE Adverse Event Report: TORNIER INC MINI MAXLOCK EXTREME ISO PLATE SYSTEM; 1.6MM ISO DRILL BIT

Catalog Number MXM-072-ISO-16

Device Problem Material Integrity Problem (2978)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/24/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during a case a 1.6mm iso drill bit tip broke off in the patient.The drill bit tip remains in the patient's foot.

• Brand Name: MINI MAXLOCK EXTREME ISO PLATE SYSTEM
• Type of Device: 1.6MM ISO DRILL BIT
• 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: 9156250
• MDR Text Key: 191198988
• Report Number: 3004983210-2019-00060
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K10192
• 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: 10/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MXM-072-ISO-16
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/24/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Disability