MAUDE Adverse Event Report: TORNIER INC AEQUALIS FLEX REVIVE; SHOULDER JOINT TRIAL INSTRUMENT

Catalog Number ARS742303

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

Patient Problems Fracture, Arm (2351); Patient Problem/Medical Problem (2688)

Event Date 06/17/2019

Event Type  Injury  

Event Description

It was reported that subject: 018-00132: fracture noted after trialing.By-passed with longer stem and cemented (revive trialing, no defect of component but fractured patient's arm while trialing).

• Brand Name: AEQUALIS FLEX REVIVE
• Type of Device: SHOULDER JOINT TRIAL INSTRUMENT
• 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: 8741412
• MDR Text Key: 149418156
• Report Number: 3004983210-2019-00035
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181420
• 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: 06/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ARS742303
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/18/2019
• 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): Required Intervention
• Patient Age: 77 YR