MAUDE Adverse Event Report: TORNIER INC AEQUALIS HUMERAL NAIL SYSTEM; INTRAMEDULLARY NAIL

Catalog Number 0020500

Device Problems Device Dislodged or Dislocated (2923); Unintended Movement (3026)

Patient Problem Failure of Implant (1924)

Event Date 05/21/2019

Event Type  Injury  

Event Description

It was reported that during a routine post op visit, xrays showed a prominent proximal screw- indicative of loosening of the screw.The subject underwent screw removal in an outpatient surgical setting.No other effects noted in report.Subject: (b)(6).

• Brand Name: AEQUALIS HUMERAL NAIL SYSTEM
• Type of Device: INTRAMEDULLARY NAIL
• 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: 8697172
• MDR Text Key: 147941818
• Report Number: 3004983210-2019-00026
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082754
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 0020500
• Device Lot Number: BP0118039
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/30/2019
• 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): Required Intervention
• Patient Age: 81 YR