MAUDE Adverse Event Report: TORNIER INC AEQUALIS FLEX REVIVE; FLEX REVIVE ASSEMBLY SCREW 0MM

Catalog Number ARS655101

Device Problems Detachment of Device or Device Component (2907); Unintended Movement (3026)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 03/05/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Devices were revised due to dissociation.Subject (b)(6).

• Brand Name: AEQUALIS FLEX REVIVE
• Type of Device: FLEX REVIVE ASSEMBLY SCREW 0MM
• Manufacturer (Section D): TORNIER INC; 10801 nesbitt avenue s; bloomington, mn
• Manufacturer Contact: mary mcnabb ; 4375 e park 30 drive; columbia city, in ; 3713153
• MDR Report Key: 9897202
• MDR Text Key: 202730122
• Report Number: 3004983210-2020-00012
• 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
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: ARS655101
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/06/2020
• Initial Date FDA Received: 03/30/2020
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR